Quality Assurance Director Jobs in New Jersey

Job Title: QA Manager / Quality Assurance Manager - Pharmaceutical API a must Company: HireSource Solutions Location: Gibbstown, NJ Description: QA Manager - API expereince desiredPlease do NOT apply if you are not local - no relocation assistance provided - local candidates onlyMust be a US Citizen or Green Card Holder - Client will NOT sponsorTo be considered for this role, you MUST have prior Pharmaceutical experience and or experience in a FDA regulated environment.API expereince is a MAJOR plus.QA MANAGER    SUMMARY OF POSITIONThe Quality Assurance group will report through the Manager to the Director.  The Manager shall be responsible for GMP compliance in the facility on a day-to-day basis.  The incumbent will work to make improvements in regards to GMP standards, leading and implementing new initiatives.  The incumbent will coordinate all customer audits, preparing the response and monitoring the implementation of corrective actions. The incumbent will be the point person on FDA audits, assisting the Director with strategy and response.  The incumbent will cross-train to support other functions within Quality Assurance Compliance and Regulatory areas. The incumbent will assist fellow employees with compliance issues.   The QA Manager will manage the day-to-day affairs of FDA audits, supervising the retrieval of documents and preparing any required response.  The incumbent will explain company position on any issues discussed with the agency.  The incumbent will write and revise Standard Operating Procedures, as required and independently prepare or alter SOPs that S/he finds are needed.  The incumbent should have a working knowledge of how electronic record keeping affects the pharmaceutical industry, and become familiar with the Company’s involvement with electronic records (21 CFR Part 11). S/he must have a working knowledge of all SOPs, CGMPs, and Company Regulations that directly affect the position, and a firm familiarity with all others procedures that affect the Company as a whole and that affect the pharmaceutical industry.  BACKGROUND Bachelor’s in Chemistry with a minimum of 10 years’ experience in the pharmaceutical industry; or a Master’s in Chemistry with a minimum of 8 years experience in the pharmaceutical industry.  Ph.D. in chemistry with at least 5 years experience in the industry.  Degrees in related technical disciplines are acceptable.  At least seven year’s experience in a job in an FDA regulated environment.  API experience strongly preferred. Excellent communication skills, particularly technical writing skills, are mandatory.  Organic chemistry knowledge required.  Knowledge and previous experience with CGMP and 21 CFR Part 11 required.  Experience with DMF filings also required. If you are qualified: Please forward your resume in WORD. Please include your salary requirements.  Your resume will be held with strict confidence and will NEVER be forwarded to any of our clients without your permission. If you are NOT interested or unqualified, please send us a referral. This is an immediate and urgent need for our valued client and therefore, we are offering a $1000 refer-a-friend fee to anyone who leads us to a candidate who is hired for this position.Word .doc formatted resumes and salary requirements to:  Mike IredaleHireSource Solutions Register to View -source.com  www.hire-source.com MORE JOBS?? http://www.hire-source.com/listings.html  HireSource recruiters are dedicated to working with the finest technical professionals throughout the country. We know the market. We know the hiring managers. We have the knowledge, resources, and contacts to make your search more complete and efficient. Whether you are looking for more opportunity, a shorter commute, better benefits, or a higher salary, we’re the best chance there is to uncovering that position you never even knew was available.

Job Title: QC/QA Manager Company: Smith Hanley Consulting - Pharmaceuticals Location: Kinnelon, NJ Description: If you are interested in growing professionally within an innovative, highly respected organization, we invite you to explore this excellent growth opportunity!!!  Smith Hanley Consulting Group is looking for a QC/QA Manager needed for a Biotech Manufacturing Company near Marietta, Georgia.  This is a 6 - 12 month consulting position so the candidates must be within a commutable distance from the facilities.  This is for candidates with GLP and GMP experience. Job description: o In charge of overall Quality Control/Assurance program including ISO and CLIA. o Create and maintain Quality Control/Assurance program. o Establish and maintain documented system for QC/QA, ISO and CLIA compliance. o Monitor and review product quality. o Assure compliance to specifications on raw materials and manufactured goods. o Oversee QC/QA, ISO and CLIA program and activities. o Provide training in QA, GMP and CLIA. o Other duties as assigned. Minimal requirements: o Must have a Bachelor's or Master's degree in Biological/Medical Sciences or equivalent. o At least 4 years experience in management of QC/QA, ISO, FDA Regulatory and/or CLIA compliance. o Excellent management, interpersonal, communication and computer literacy skills. o Highly self-motivated with leadership ability. Fluency in both English and Mandarin a huge plus, but not a requirement., Not Specified PLEASE APPLY USING THIS BUTTON ONLY

Job Title: Quality Assurance Director Company: MRINetwork Location: Morristown, NJ Description: Quality Assurance Director Responsibilities will include, but are not limited to:Overseeing the quality systems in the development, testing, manufacture, and packaging, while ensuring overall compliance to internal GMP procedures and external regulations. Manage, train, & support of all QA/QC department employees. Educate all employees on GMP systems requirements, compliance expectations, and help prepare company and serve as primary contact for all regulatory and client-related audits. Develop, originate, & revise SOP's, Master Batch Records, raw material and finished product specifications Thru the development & management of long-term & short-term regulatory strategic plans, provide leadership and technical expertise to identify needed improvements to current GMP systems, procedures, and practices to achieve full compliance with FDA.  The ideal candidate should have a background in the food or pharmaceutical industries with knowledge of industry regulations, GMP's and laboratory procedures.  The candidate should possess strong problem solving skills with the ability to analyze data, effectively summarize findings, and draw conclusions.  Must have strong communication skills with the ability to positively influence change at all levels of the organization.  Manufacturing/R&D/laboratory background a plus.  High level of knowledge of FDA-related regulations a plus.  Potential employee should have an advanced degree in related studies, 10+ years QA/QC experience in related field.Reply in Confidence. Contact: Company: Davalyn Corporation Job Reference Code: 10-15-10 Send this job to a friend

Job Title: Head of QA/ Sr. QA Manager Company: Design Strategy Corporation Location: Jersey City, NJ Description: Our direct client is in need of a Sr. QA Manager / Head of QA to lead their Quality Assurance Group within clients of Fixed Income/Derivatives Technology group. The successful candidate must be able to work independently while actively participating in a global team. This role will provide the candidate selected with a tremendous amount of diversity, personal and professional growth. FI/Derivatives Technology Group is in the beginning stages of a major multi-year project to develop, enhance and support our new strategic platform for fixed income and derivative products. Client's new high performance system will use distributed computing technologies to deliver a platform capable of sub-millisecond matching at very high sustained loads while achieving five nines availability. Quality Assurance is a crucial part of this effort and an area of major investment to improve the automation, scale and quality of testing. The successful candidate will lead and manage a team of approximately 8-10 onshore testers, engineers and test leads responsible for the functional and regression testing of their application software, assuring software releases of the highest possible quality onto their platforms. In addition to the onshore team a newly established offshore team is helping to increase automation and the scale of execution. Client will be making significant investments in test tools and test script automation that will provide us with enhanced capabilities in responding to the needs of the business. Suitable candidates will need to demonstrate a track record in leading comparable Quality Assurance groups within the financial services arena.

Job Title: Manager of Quality Assurance Company: Hobart West Solutions Location: Mountainside, NJ Description: Multi-national medical device company creating a new position to provide for the development and implementation of quality systems.Policies and Procedures.  Experience in working with FDA is a plus.  The position reports to Company President and is located in Mountainside, NJ. Responsibilities:Generate, implement and maintain internal quality procedures and systems to comply with applicable regulatory requirements.Ensure an effective Corrective Action Preventive Action Program.Ensure effective document control and change control process.Ensure customer complaint records are maintained.Establish a companywide training program that complies with cGMP requirements.Preparation of 510K filings.Solid understanding of cGMPs and FDA guidelines is required.

Job Title: Director of Quality Assurance - Medical Device Manufacturing Company: MRINetwork Location: Paterson, NJ Description: Director of Quality Assurance Medical Devices  A world leader in the medical device manufacturing industry has an opportunity available for a Director of Quality Assurance. This position carries the responsibility for company-wide quality vision and leadership, develops site objectives, and drives quality processes throughout the corporation.  The company manufactures a full line of disposable, durable, and implantable devices in multiple states domestically and in multiple countries globally. Additionally, there is a full pipeline of exciting new products and technologies that will be receiving FDA approval in the near future. This is one of the top ten medical device companies in the world.  This position is located in the Northeastern US. A complete relocation package is available. Please send a resume if you are interested in discussing this position.  QUALIFICATIONS ·         BS or MS in supporting discipline·         15+ years experience in the medical device industry·         Quality system design and implementation experience·         Experience building robustness into processes and creating systems for quality·         Broad knowledge of medical device manufacturing methods·         A successful history demonstrating vision and leadership Please respond to this advertisement by attaching your resume in MS Word format to an email addressed to Register to View and John Boynton at MRI Atlanta Peachtree North will give you a call if you meet the requirements.  Please send a link if you are interested in joining my network of 8000+ industry executives on LinkedIn.                       Keywords, medical devices, abatement absorbable advanced affairs anal analysis analyst anesthesia anesthetic angioplasty aorta aortic appendage antimicrobial arm arrhythmia 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Job Title: QA Manager/JAS Company: Shain Associates Location: Berkeley Heights, NJ Description: Seeking a full time QE Manager to work in either our Fairfield, CT office or NJ facility. This is an exciting opportunity for creative individuals who want to combine the environment of a startup with the resources and stability of an established company. The ideal candidate will be responsible for designing and developing a cost effective, long-term automation strategy promoting reusable components, low maintenance costs, high efficiency and scalability. The scope of the position is:•      Designs, researches and develops strategy and test architecture for a new platform•      Designing an infrastructure to validate the requirements, functionality and performance goals for the particular product This is a “hands on” position where the person will be expected to dive into the requirements of the Quality Engineering department, and plans the development of manual and automated regression tests to be implemented for a new platform.  It is expected that the candidate in this position will work with Software Development groups, QE Engineers, as well as in-house and over-seas contracted personnel.  The candidate will have strong people and lab management skills.  Solid communications and project management skills will be required. The person must satisfy required experience and must be passionate about staying current with the latest test automation tools on the market, as well as constantly striving to apply the latest in enhancement techniques into the IPC test automation platforms. Continuously demonstrate ability to propose and develop innovative ideas resolving business or project related issues.•        Responsible and accountable for the activities and performance of the Quality Engineering discipline•        Ensure that the discipline is operationally efficient at all times and its activities stay within the approved budget•        Represent the Quality Engineering discipline’s interest at the executive and cross discipline level•        Represent the Product Development Organization at internal and external events as required•        Participate in the development of the company’s Product Plan. Develop the Quality Engineering portion of the company’s Product  Development Plan (resources, schedule, budget)•        Responsible for leading large or multiple mid-size geographically spread complex projects requiring increased technical knowledge.•        Maintain and coordinate the use of multiple test hardware platforms.•        Establishes and communicates common goals and direction for project test team.•        Drive the development of overall software test strategy and approach, project schedules and milestones.•        Lead staff in the preparation and conduct of testing of new or revised applications/systems and ensure tests are successfully completed and documented. •        Develop and lead offshore QE strategies•        Provide up-to-date information on project status defects, issues, and project risks.•        Lead the development of a consistent testing methodology. Ensure appropriate standards and practices are documented, maintained and applied to all projects and services supplied by the discipline.•        Develop overall readiness and risk assessment of new or revised applications/systems and presents to management.•        Assigns/Removes Quality Engineering resources to/from a Project Team•        Apply appropriate performance metrics, analyze the results and take appropriate actions to ensure the continuous improvement of the discipline (time to market, quality)•        Identify, acquire and/or train as necessary, the skill set required to maintain the discipline’s capabilities and competencies to meet the demands of the Product Development Plan•        Champion the Product Development Process within the discipline and across the company at all levels•        Ensure company policy is enforced in administrative matters (performance reviews, timesheets, vacation time, purchase orders, expense reports, etc.)•        Review all commitments made by discipline members to ensure they can be realistically achieved and follow up to make sure they are met (risk management)•        Provide an escalation point for Project Management to resolve project issues related to the discipline •        Over 12+ years experience in Quality Engineering, business/systems analysis or programming•        Previous architectural experience in designing and developing automation test frame works for software based telecom switching solutions •        5+ years experience managing mid to large-size projects and staff •        5+ years experience managing offshore projects and teams •        Experienced in leading development of automated tests using QTP/Load Runner and/or other tools•        3+ years test experience with real time, PC based, WEB-based, distributed applications deployed on J2EE, Linux, Unix, Windows, and VxWorks.•        Programming experience  •        Experience in telecommunications, IP, Networking protocols, architectures and applications is a must•        Experience in security, including security of networks, servers, and VoIP systems.•        Experience with telecom Gateways, Media servers, and Application Servers, and PBXs from vendors like Cisco, Avaya, Nortel,  Lucent/Alcatel.•        Experience with scripting languages including Python, Perl, and Shell. •        Excellent communication skills including written and spoken English as well as the ability to present complex technical and behavioral topics to diverse groups during conference calls and large meetings. •        Demonstrate a proven ability to manage multiple high priority tasks with competing priorities. Must be highly organized and detail-oriented. Proactively address issues, be a self starter.•        Knowledge of general Software Engineering life cycle development methodologies.•        Excellent written and verbal communication skills.•        Ability to analyze and balance facts, priorities, and alternatives to make sound decisions and recommendations.•        Ability to evaluate past decisions to improve effectiveness of future decisions and development efforts.•        Ability to understand and communicate complex technical concepts to all levels of the organization.•        Outstanding problem solving skills, including the ability to look for non-standard problem solutions, this is key to this position.•        Ability to learn and apply new technologies and learn and understand details of third party applications and technologies.•        Firm knowledge of Software Development Lifecycle and Test methodologies (Rational Unified Process, Agile development). •        Proven ability to manage multiple projects, geographically spread teams under tight deadlines, often with competing priorities and complexities •        Ability to prioritize along critical path and meet project milestones and deliverable dates •        Proven working knowledge of testing methods, tools, and software testing best practices ( such as Mercury QTP, Load Runner, Rational ClearQuest) •        Ability to understand and translate business requirements and Use Cases into testable requirementsREQUIRED EDUCATION•        Bachelors Degree in Computer Science or Electrical Engineering is required.•        Masters Degree in Computer Science or Electrical Engineering is preferred.Please refer to job code JAS when responding to this ad.

Job Title: QA Manager for Medical Distributor Company: KSR Location: Piscataway, NJ Description: Kelly Scientific Resources seeks to identify a QA Manager for a medical diagnostic supply distributor who would generate, implement and maintain internal quality procedures and systems to comply with applicable regulatory requirements. This is a temp-to-hire opportunity for an individual with expertise in Quality Assurance, capable of responding to FDA complaints and effectively bringing a company up to compliance. Responsibilities will include establishing a company wide training program in keeping with cGMP requirements; ensuring effective document control and change control processes; implementing effective CAPA Programs; and establishing an effective process for the maintenance of customer complaint records and resolutions. Our client is a relatively small, traditional company with global partners. This position is a new role created out of necessity due to the rate at which this company is growing. They are looking to hire immediately! The contract period will be roughly 3-6 months. Pay: $40-45/hr For immediate consideration, press the APPLY NOW or SUBMIT RESUME button below.

Job Title: Charles River Order Management QA Specialist Company: Axelon Services Corp Location: Pennington, NJ Description: Charles River Order Management QA SpecialistPennington, NY1 YearNOTE: I AM LOOKING FOR A SENIOR QA ANALYST WITH CHARLES RIVER ORDER MANAGEMENT EXPERIENCE. SOMEONE WHO HAS WORKED ON A CHARLES RIVER PROJECT FOR AT LEAST 5-6 YEARS AND KNOWS THE SYSTEM. I WILL NOT ACCEPT ANYONE WHO IS CURRENTLY WORKING FOR CHARLES RIVER OR HAS IN THE LAST 12 MONTHS. I AM WELL AWARE THAT THESE SPECIALISTS ARE COSTLY SO IF YOU FIND SOMEONE ABOVE THE RATE CARD RATE PLEASE SUBMIT THEM AT THE RATE YOU REQUIRE BUT KEEPING IT WITHIN THE 110-120 RANGE.River Order Management QA Specialist - recent relevant experience (cannot have worked directly for CRD in last 12 months). CRD Trade Order Lifecycle (Equity, Fixed Income, Mutual Funds and Options). Experienced batch cycle ( of order management using batch cycles - Autosys jobs) This is a QA role, not an implementation roleQualification, RatingQA ToolsQA, 0 (No Familiarity) of 5 (Expert) and 0+ Yrs.

Job Title: QA Director for Investment Banking Company: Futures Group IT LLC. Location: Jersey City, NJ Description: Please send resumes to Register to View or call Register to View and ask for Eric for more details. Premier Investment firm is seeking a QA Director to run a global team supporting the full Quality Assurance lifecycle of front office trading applications. The successful candidate will lead and manage a team of approximately 15-20 onshore testers, engineers and test leads responsible for the functional, regression, integration and performance (capacity) testing of trading application software, assuring software releases of the highest possible quality. In addition to the onshore team a newly established offshore team is helping to increase automation and the scale of execution. The firm will be making significant investments in test tools and test script automation that will provide enhanced capabilities in responding to the needs of the business.Key day-to-day responsibilities include, but are not limited to:* Manage the development and maintenance of test tools and automation scripts.* Oversee / orchestrate the efforts of four to six project test teams simultaneously.* Delegate the development of manual and automated test scripts.* Review and provide feedback on business requirements, functional specifications, software designs, test plans, and test reports.* Support investigation of production issues.* Manage staff schedules.* Produce quality metrics for the organization* Keep testing platforms and tools in line with the technology curve.* Perform performance appraisals.Financial industry experience is preferred, but not required as long as candidate comes from a large global environment and has senior QA management experience.