QC Director Jobs in New Jersey

Job Title: Pharmacovigilance Quality Manager - Animal Health-REG0000101 Company: Merck & Co. Inc. Location: Roseland, NJ Description: Pharmacovigilance Quality Manager - Animal Health-REG0000101 DescriptionMerck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Prime Responsibility: To take ownership of Pharmacovigilance Quality Management including the audit and inspection responsibilities involved in Global Pharmacovigilance for Intervet/MERCK Animal Health. Duties include, but are not limited to: Coaching colleagues in international pharmacovigilance and country operation locations to prepare for internal audits and external regulatory inspections. Assisting colleagues during the course of inspections and audits. Reviewing and Monitoring corrective/preventive action (CAPA) plans in response to audit or inspection observations. Developing documents (SOPs, business procedures) and implementing these as responses to audits and inspections and quality initiatives. Assisting other colleagues as they draft CAPA plans. Ensuring that commitments made in response to CAPA observations are met in a timely manner. Developing a system to permit the tracking, including progress and completion, of commitments arising from CAPA's for regulatory inspections, internal audits and from regulatory actions for marketing authorization commitments. 40 % International Travel. Qualifications BS/MS in Life Sciences; Pharmacy; Veterinary Medicine; or Nursing 5 years minimum in a process driven work flow environment such as Quality Assurance or Pharmacovigilance or Regulatory Affairs -- which must include -- 2 years minimum experience in Pharmacovigilance. Experience in the development of processes and procedures. Expertise in quality assurance and management. Excellent communication skills. Computer skills should include data base usage. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Job Title: Quality Control Manager - Flavors Company: Firmenich Inc. Location: Newark, NJ Description: Employer Information About Firmenich Inc. We are a leading international company with headquarters in Geneva. Our reputation for excellence as a creator and manufacturer of specialty chemicals, flavors and perfumery products is recognized worldwide. From our award-winning fragrances to our irresistible candy ingredients, our team has been combining experience and innovation to perfume and flavor our clients' products for our mutual success. Their passion has not only helped create many of the world's best-selling perfumes, cosmetic....more info View all our jobs Job Firmenich has an exciting opportunity for an ambitious individual to be part of a flavor plant start-up. We have a an opening for a Quality Control Manager - Flavors The successful candidate will assure the overall implementation and effectiveness of the Quality Program of flavor production, oversee all aspects of the organization's Flavor Quality Control Department, and quality improvement efforts, such as developing and administrating the program, training and coaching employees and facilitating change throughout the organization and be responsible for establishing strategic plans, policies, and procedures at all levels to insure quality improvement efforts meet or exceed internal and external customer's needs and expectations. Job Responsibility * Responsible for the efficient and effective operation of the Quality Control Department including sensory, analytical, and micro controls. This includes oversight for detecting, reporting and correcting product failures, purchased RM rejections, and maintenance and calibration of QC equipment. * Responsible for the Food Safety Programs (e.g. cGMP's, HACCP), Audit programs (e.g. internal, customer), Third Party Certifications, Quality System Documentation and Training Programs and Customer Specification Management. * Responsible for handling customer complaints with customer dialogue and problem resolution as well as Communication on Vendor issues. * Main Liaison to Business Division, SCIN and Creation on issues related to new product introductions. * Main Liaison to Supply Chain on all technical matters. * Responsible for all Quality Improvement Programs * Responsible for monitoring and reporting Quality performance. * Provides Technical Support to other manufacturing centers for Durarome (California, Florida and Brasil) * Perform other duties as required.

Job Title: Quality Manager Company: IntraPac Group Location: Swedesboro, NJ Description: The IntraPac Group is a specialty packaging company providing a broad array of packaging solutions to the personal care and pharmaceutical markets. Our product offerings include plastic bottles, closures, vials, jars, laminate and tin tubes, deodorant sticks, cannulas, droppers and specialty coating services. Our technologies extend from extrusion, injection and injection stretch blow molding, through injection molding, metal extrusion, laminate tube production, and specialty coating equipment, and we provide specialty decorating and assembly services to our customers. Through our seven production facilities spanning North and Central America, we have expertise in working with a wide array of materials including PET, HDPE, LDPE, polypropylene, aluminium barrier and plastic laminates, metals and specialty fluoropolymer coatings. We are seeking a skilled, hands on Quality Manager for our Swedesboro, New Jersey location.  The Swedesboro location is a unionized plant producing injection molded components and laminate tubes 24 hours per day, 5-7 days per week for pharmaceutical and personal care markets.  Role will report into Technical Manager.  This position has growth opportunities into more a technical/management role/responsibilities.  Job Purpose: Effectively manage the quality system and personnel to assure that quality product is being produced and customer requirements are being met.   Responsibilities:Implement, review, approve and maintain Quality Manual, standard operating procedures, forms, and all other quality documentation.Drive continuous improvement throughout organization.Manage customer process including investigation of customer complaints, performing corrective actions, and providing written responses.Manage supplier complaints/claims.Conduct supplier/customer meetings.Work with customers and suppliers to establish acceptable quality standards for new products.Oversee internal and external quality system audits.Monitor supplier performance and perform vendor audits.Responsible for the development and improvement of inspection methods, equipment, and control techniques.Manage gauge calibration and gauge calibration records.Manage quality records.Maintain monthly quality KPI’s.Produce and maintain specifications for internal and external products.Perform quality-related studies and tasks as needed.Conduct job specific training and development.Other ad hoc analysis and project work as required. Qualifications/Requirements: Bachelor’s degree in Engineering related field.Minimum 2 years experience in Quality Systems Management.Experience with ISO 9001:2008 required.Knowledge of current good manufacturing practices (cGMP) required.Experience with packaging, injection molding, and/or plastics desirable.ASQ Certification preferred.Six Sigma experience preferred.Good communication skills for customer and supplier interaction.Proficient in Word, Excel, Access and Lotus Notes. 10% domestic and international travel.  Company offers competitive salary, full benefits, and 401(k). Local candidates only, no relocation provided.Interested, qualified candidates should submit resume to Register to View  .

Job Title: Quality Supervisor Company: Liberty Personnel Services Inc Location: Three Bridges, NJ Description: Quality Supervisor Job Description A well respected NJ employeer is seeking a  Quality Supervisor for a Food Manufacturing company.Supervision of QA Techs - overall quality analysis of food product. Raw materials, in-process, and finished product quality analysis - basic wet chemistry- pH, moisture, etc. Manufacturing quality inspection and evaluation based on GMP and HACCP regulation Evaluation of overall plant processes  Job Requirements Qualified Quality Supervisor candidates should meet the following requirements: 5-10 years of experience in food quality with at least 2 years experience as a Supervisor Strong knowledge of cGMP and HACCP Knowledge and experience with Microbiological lab procesures Attach a resume and send  today directly to Register to View

Job Title: Director Quality Improvement Ini Company: American Heart Association Location: New Brunswick, NJ Description: Job Title: Director Quality Improvement InitiativesCategory: HealthcareLocation: New JerseyJob Description:What's your motivation? For some it's the opportunity to do extraordinary work or to develop challenging new skill sets. For others it's the ability to make a difference in people's lives or take on growing levels of responsibility and leadership. However you define your professional goals, you have the opportunity to achieve them at the American Heart Association.The Founders Affiliate of the American Heart Association is recruiting to fill Quality Improvement Initiatives position based in our Robbinsville, NJ office. Under the direction of the Vice President of Quality Improvement, the Director is primarily responsible for overall implementation activities in defined markets to achieve program goals (Coronary Artery Disease, Heart Failure, Stroke and all other modules). Other duties will be based on implementation responsibilities assigned by the VP Quality Improvement Initiatives (QII). Defined territory for this position is New Jersey.Major Responsibilities:- Identifying, cultivating and maintaining key market stakeholder relationships impacting program goals such as: local business coalitions, hospital systems or health plans.- Likely serve as Account Manager for state of stakeholder relationships impacting program goals such as Departments of Health or Quality Improvement Organizations as assigned by Vice-President QII- Overall customer relationship management including use of Siebel (association customer database).- Coordinate and conduct GWTG account management activities for assigned A, B and C hospitals in market including implementation and quality improvement consulting.- Market and implement the program including the Patient Management Tool.- Provide hospital training sessions for PMT data entry and PMT data reporting as needed.- Consult with appropriate hospital teams with respect to the compliance issues and strategies- Responsible for the accredited and non-accredited workshops in primary market.- Interact with appropriate affiliate staff and volunteers to leverage opportunities and provide seamless customer relationship management.- Execution of all necessary pre-work activities required to launch all future GWTG modules in a market including: the oversight and execution of ASTP, JCAHO Primary Stroke Center and similar programs as necessary.- Trouble-shooting and follow-up on specific customer issues.- Conducting follow-up activities with the hospitals.- Facilitating all elements of the Get With The Guidelines program, under the supervision of the SRD QII.- Other duties as assigned by the VP, QIIFor qualified candidates this position offers a salary, and a wide range of benefits .Please review the Qualifications section below to see if you meet the requirements for this position.Attracting talented, committed employees means offering a competitive benefits package, ongoing professional development and training, and a diverse and inclusive environment in which to work and grow. And we do.To apply for this position or to see other opportunities with the American Heart Association please visit www.americanheart.org/careers. We no longer accept mailed, faxed or e-mailed resumes. Please apply for positions directly through our website. Only those candidates deemed most qualified by the hiring manager will be contacted to interview. EOE M/F/V/DExperience:The requirements listed below are representative of the knowledge, skills and ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.' 2+ years experience in a hospital/healthcare setting (QI, RN, Case Mgmt, other clinical)' 2 years professional experience in managing and building relationships preferred.' Knowledge of public health a plus' Knowledge of heart disease and/or stroke also a plus.' Results driven with the ability to multi task' Willing and able to travel in required territory at least 50% of the time. Some overnight travel will be needed.' Valid driver's license, proof of at least minimum state required automobile liability insurance and ability and willingness to travel as position demands.' Satisfactory background checks including consumer credit, motor vehicle, and criminal history.Education:' Bachelor's degree in healthcare or a related field, Master's degree preferred.Supervisory Responsibilities:None

Job Title: Mgr, Quality Company: Siemens Location: Flanders, NJ Description: '); } } checkframes(); Skip Navigation Job Details Mgr, Quality Company Siemens Healthcare Diagnostics Inc. Division SMSD - IVD OPS Functional Area QC - Quality Location NJ - Flanders Req ID 85016 Job Type Regular Job Time Full-Time Experience Level Senior Level Required Education Bachelors Degree Required Travel 20% Company Description Siemens Healthcare Diagnostics Inc.  offers a broad portfolio of performance-driven diagnostic solutions that provide more effective and efficient ways to anticipate, diagnose, monitor and treat disease.  Our products and services offer the right balance of science, technology and practicality across the healthcare continuum to provide medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe.  Visit us at www.siemens.com/diagnostics. Siemens is an Equal Opportunity Employer encouraging diversity in the workplace. Job Description Responsible for developing and coordinating quality focused activities to monitor and improve Instrument products and processes. 2.             Responsible for supporting decision making process concerning part/product performance issues and ensuring appropriate investigation, documentation and notification to internal personnel, as required. 3.            Responsible for the handling and management of the Supplier Quality Assurance and Final Product Release activities. 4.            Staff and develop the Supplier Quality Assurance and Final Release functions. 5.            Budget and administer expenditures for the group. 6.         Responsible for developing & strengthening Supplier Quality Programs.   7.       Interact routinely with Purchasing, Engineering & Suppliers to proactively improve quality of components. 8.     Responsible for understanding the Quality Management System. 9.     Incumbent needs to integrate their knowledge of the quality policy and business objectives into their work practices to augment the business such as: participating in internal audits, identifying areas which need improvement, implementing plans to correct and prevent problems. 10.  A key responsibility of this position is to ensure that their area of responsibility is in compliance with the FDA, ISO and IVDD standards Qualifications ·          Bachelor’s Degree in Engineering or relevant field and Certified as a Quality Auditor or a Certified Quality Manager; or the equivalent in related work experience. ·          Minimum of 5-8 years of professional level experience in a manufacturing operation. ·          Previous experience in a FDA and/or ISO regulated environment necessary. ·          Requires excellent facilitation and communication skills, both oral and written. ·          Needs to be able to exercise independent judgment to determine project guidelines purpose follow-through, and completion. ·          Ability to effectively work with all levels of employees and business representatives from other organizations. ·          Supervisory Ability - Managing and Developing Subordinates – expected to be able to provide challenging tasks and assignments with the appropriate degree of empowerment; is a people builder.  Able to act as a mentor and provide on-going constructive feedback.

Job Title: Manager, Quality Management - PHARMA ONLY Company: Alternative Resources Company Location: Piscataway, NJ Description: Role Title: Manager, Quality Management Department/Group: Quality Management Career Level: S/P3 Supervisor: Director – Quality Management Date:  February, 2010 Position Overview Assesses and communicates the state of clinical trial and drug manufacturing activities with regard to Regulatory compliance to QM Director. Provides review, guidance and oversight to assure company activities are in compliance with regulatory requirements, industry standards and corporate objectives/mandates. Essential Job Responsibilities/Primary Activities Provides quality control and assurance review of submission documents which includes (but is not limited to) the following: all submission documents such as INDs, NDAs, IB, protocols, annual reports, informational amendments, etc. to ensure that documents are written in compliance with regulations, guidelines, SOPs and other procedural documents Assists with planning audits and conducting external/internal compliance audits which includes (but not limited to) the following: investigator sites, vendor audits (CROs, Phase I units, Clinical Labs, internal system audits etc.). Serve as lead auditor, as assigned, in multi-auditor situations and authors audit reports which meet industry standards, company expectations, and require minimal input by Supervisor. Develops, implements and manages process for audit reports, responses, communication of significant audit observations as well as evaluate the adequacy and completeness of corrective and preventative action plans, and follow-up to closure as required. Accountable for reporting to QA management on the accuracy, quality and integrity of activities and processes respectively conducted and implemented within Clinical/Clinical Operations. Contribute to process improvement initiatives across the organization such as (but not limited to): assisting in the CAPA program and assist in facilitation of the CAPA plan, present audit results to various client groups, and verify corrective action implementation. Provides consultative support to internal staff on issues relating to GXP, such as GMP, GLP, GCP and computer system, compliance topics. Conducts peer review of internal and contracted audit reports as needed. Active participant to promote global harmonization, including development and technical support of global audit database and creation/review of standard operating procedures. Maintain up-to-date working knowledge of national regulations, guidelines, industry standards related to performance of clinical trials in the Americas, and may train on standard operating procedures and work instructions, GCP, compliance, auditing, etc. May recommend audits for QM audit plan and communicate audit results and associate relevant regulatory risk to Clinical teams. May assist Director with regulatory authority inspection and other types of audits as needed. Performs other department duties as assigned. Qualifications n Degree in Life Sciences Required: Bachelors  Preferred: n Minimum 4 years experience as an auditor in Clinical Research n Knowledge of GXPs with emphasis on GCP experience n Understanding of clinical development process Career Map Framework General Profile n Has in-depth experience, knowledge and skills in own discipline n Uses relevant practices and knowledge to develop products, processes, etc. n Solves moderately complex problems; takes a new perspective on existing solutions n Works independently with minimal guidance n Acts as a resource and mentors others with less experience; may project manage small teams, within and outside of own department; may have global scope Career Map Framework Dimensions (Detailed descriptions of career level dimensions) Expertise Scientific/ Professional Expertise n Has in-depth experience, knowledge and skills in own discipline n Uses current relevant practices and knowledge of internal/external scientific/professional issues to develop and improve products, services or processes in own discipline Regulatory Compliance n Develops the internal compliance environment, e.g., reviewing and revising SOPs n May oversee and ensure compliance and regulatory expectations within scope of projects or teams Delivering Solutions Problem Solving n Solves moderately complex problems; takes a new perspective on existing solutions Customer Focus n Interprets internal/external customer needs, assesses requirements and identifies solutions to non-standard requests Impact Influence n Explains difficult issues and works to establish consensus Decision Making n Makes operational decisions affecting product, processes, services Resource Management Project Management/ Coordination n Acts as a resource and mentors others with less experience; may project manage small teams, within and outside of own department; may have global scope n May forecast and plan resource requirements Financial Management n Monitors and controls costs within own work and costs for department n Makes recommendations to budget Debra Pohl President, Pharmaceutical Recruitment Alternative Resources Company Register to View

Job Title: DIRECTOR QUALITY OPS LATIN AMERICA Company: Bristol Myers Squibb Location: New Brunswick, NJ Description: Title: DIRECTOR QUALITY OPS LATIN AMERICA Location: NJ-New Brunswick This position oversees systematic implementation and management of quality programs in Latin America to assure compliance with all principles of current Good Manufacturing Practices and to avoid recalls or other regulatory action. Provides strategic quality leadership to Latin America Operation. Is responsible for all quality and compliance activities within the region including FF and recall actions. Manage and oversee the commercial quality units. Provide quality oversight and maintain distribution model practices in the region. Global travel 40-50%.-BS in Natural Science, Chemistry, pharmacy, biology or a related pharmaceutical science. Masters degree preferred. -Minimum of 10, ten, years of progressive managerial experience within the quality control function of the pharmaceutical health care industry and regulatory agencies. -Extensive knowledge and experience in pharmaceutical health care operations, manufacturing, pharmaceutical health care technology, quality control and federal international regulations are essential for appropriate decision making ability and representation to regulatory agencies. Previous experience as BMS QC QA site director and or assignment in a Headquarters QC QA function highly desirable. -Demonstrated ability to develop and apply BMSs operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas. -Proficient in cGMPs and FDA EMEA regulations and requirements and application to laboratory, operations and distribution practices. -Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important for evaluating the potential impact of product decisions. -Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management. -Must be innovative and creative and utilize all available resources. -Working knowledge in PCs and Quality Systems -Excellent communication skills in English with Spanish a plus. -Other required complementary skills, Team oriented with excellent interpersonal skills. Able to switch priorities plus manage more than one project at the time. Ability to plan and conduct projects within a multi disciplinary environment, inquisitive, science technology oriented individual but practical, with an ample sense for innovation. -Effectively manage cultural and operational differences. -Strong negotiating skills for interface with regulators and external QA business.Please refer to job code bristolmyers-0900928 when responding to this ad.

Job Title: Quality Control Manager Company: Grapevine Technology Location: Englewood Cliffs, NJ Description: Grapevine Technology is seeking a Project Manager to support the Project Operations team to manage and quantify the scope and delivery of a new project. This person will be tasked with managing activities related to Scope Control management and Scope Quality Assurance management.Knowledge of Scope Management, Scope Change, and Scope Control are required for this role. The candidate will be tasked with the development and management of the process to manage the quality of delivery of the systems, process, and value creation solutions over the program development, design, and implementation.

Job Title: Manager, Quality Control - Microbiology Company: Dendreon Corporation Location: Morris Plains, NJ Description: Dendreon is seeking a Manager, Quality Control for our New Jersey Microbiology Laboratory, Night Shift operations. This is an exciting position accountable for providing leadership, management and delivery of compliant laboratory data in support of Dendreon’s products and in accordance with appropriate regulatory, corporate and scientific guidelines. The successful candidate will manage the Microbiology Laboratory operations on a daily basis, as well as during inspections/audits by the FDA and other regulatory agencies. This person leads, develops and mentors reporting staff at a variety of levels. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. General Summary: Manages operations in the Microbiology Laboratory. Oversees microbiological tests performed during in-process and final product testing of Dendreon products. Monitors sample collection, testing, and data review. Manages test samples, reagents and reference standards in the Microbiology Laboratory.Conducts and manages laboratory investigations, participates as QC representative during investigations into deviations/exceptions and environmental monitoring excursions. Ensures laboratory data integrity and traceability. Communicates with Corporate QC and ensures implementation of harmonized laboratory control systems in the NJ Microbiology Laboratory. Participates in planning and process improvement activities at the departmental and inter-functional level. Sets goals, and conduct performance reviews of direct reports; performs ongoing assessment of development and training needs of reporting staff to ensure continued development of personnel. Contributes to the development of department budget and monitors expenditures. Job Requirements: B.S. degree in Microbiology, or other relevant scientific discipline. 7 years of experience in a cGMP Quality Control department in a FDA regulated industry (drugs/biologics) with at least 3 years in a leadership role; commercial phase experience required. Thorough knowledge of cGMP/ICH/FDA regulations. Experience with inspections/audits by the FDA and other regulatory agencies. Experience with LIMS preferred. Ability to prioritize and successfully manage complex and competing projects. Proficient in MS Office applications. Working Conditions and Physical Requirements: Limited travel required. Limited handling of laboratory equipment, chemicals and biological materials. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.