Description:
My company shares my passion for helping to improve human health around the world.This is My MedImmune.Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunitiesthat encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.Title: Associate Director, QA OperationsLocation: MD, Gaithersburg - Corporate HeadquartersReq: 02282Position Summary: The Associate Director of quality assurance operations position is located at MedImmune pilot plant facilities in Gaithersburg Maryland. The position manages the QA function for the clinical bulk manufacturing operations. Supervises wide range of Specialist and Quality Engineering related staff. Additionally, manage other managers and supervisors.
Job Title: MANAGER, QUALITY ASSURANCE
Company: Crown Cork and Seal
Location: Baltimore, MD
Description:
QUALITY ASSURANCE MANAGER Baltimore, MD Come join the Crown Cork & Seals team at our state-of-the-art food can manufacturing facility in Baltimore! We are seeking a Quality Assurance Manager to lead and administer the Quality program. You will be charged with encouraging and promoting an atmosphere of safety, continuous improvement and World Class Performance to meet all our customer requirements throughout the plant with all personnel. The successful candidates duties will include but not be limited to the following: Provide systems level guidance and instruction to the quality department as well as the overall operation to ensure that all are working towards the same set of goals and requirements Daily review of all process control records to ensure that internal compliance measures and customer requirements are being met. Keep management team apprised of all quality issues. Daily review of all spoilage collections assigning various types to proper source. Help develop, maintain and improve a spoilage control program Provide quality assurance training for plant hourly and management teams. Daily review and entry of all defective material related data into associated databases. Daily review of production to evaluate and determine proper disposition of questionable product and formally isolate production when required. Scheduling and tracking of plant sorting operations Key member of safety committee to participate and promote safety in the plant Maintaining accurate mill claims for all suppliers will be generated from spoilage, sorting and other databases. Generating a monthly report to detail activities at the plant. This report will include quality, production, SPC, customer concerns, supplier concerns, HACCP, plant concerns. Plant audits will be performed on a regular basis as prescribed by corporate as well as internal guidelines. Work with customers and or the sales department to resolve any questions they have, concerning quality issues. Job Requirements:The ideal candidate will possess the following; Four-year technical college degree 3+ years hands-on experience in a manufacturing environment with proven Quality Management System oversight capability. Supervisory experience a plus Proficient in Office 2000, (Excel Word, Access and Power Point). Excellent grasp and understanding of SPC (Statistical Process Control). Six-Sigma, Lean Manufacturing or strong ISO background a plus. Basic understanding of HACCP and GMPs. Good personal interactive skills are essential for the training, coaching and leading plant hourly and management teams in the Quality Management realm. Must work well with others and be able to communicate in an effective and clear manner. They must have the ability to interface with corporate engineering and customers, concerning quality and process capability. They must be very organized and disciplined in the way they perform tasks. Analytical skills must be highly developed with an ability to objectively evaluate data and perform statistical analysis. Technical writing skills provide an advantage in report development and team progress. Click Here To Apply http://crown.ats.hrsmart.com/cgi-bin/pm/click.cgi?job_id=1750&site_id=35
Job Title: Quality Assurance Manager (205265)
Company: Henry M. Jackson Foundation
Location: Rockville, MD
Description:
The Henry M. Jackson Foundation (HJF) is seeking a Quality Assurance Manager for the Department of HIV Laboratory Diagnostics and Monitoring in Rockville, Maryland. HJF provides scientific, technical and programmatic support services to the Department of Laboratory Diagnostics and Monitoring. The Military HIV Research Program (MHRP) is dedicated to HIV vaccine development, prevention, disease surveillance and care and treatment for HIV.HIV-1 continues to pose a significant and persistent threat to the military and allied forces both in terms of readiness and force protection. The brisk pace of deployments to locations throughout the world requires the MHRP to develop products and capabilities with an international scope.This program builds on the strength of the U.S. military medical research community, and addresses specific HIV research requirements to meet its mission: prevention of HIV-1 disease in the active force and, by extension, the global community at risk of infection.Responsibilities:1. Reviews and approves documents. Develops and maintains a centralized documentation system for all records.2. Ensure internal audits are performed each month and report findings at the monthly QA meeting after passing to the Lab Manager for review. Identifies critical episodes, events deficiencies, recommends remedial actions, confirms implementation of actions and reports findings to laboratory management.3. Track the receiving of Proficiency test panels and submitting of results to vendor (generate a calendar of all PTPs to be received each year, documenting date received, date results submitted, and score received). The program includes serology/immunology, Western Blot, HTV-1 RNA Viral Load, HIV Genotype, Hematology and Flow Cytometry.4. Coordinates all equipment/building validation issues and ensures regulatory compliance.5. Reviews and tracks all Standard Operating Procedures (SOPs), medical device reports and Occurance Reports. Manages monitoring, evaluation, and corrective actions and reports the results to the appropriate department level committee.6. Oversees the duties of 3 staff members: Document Control; QA Specialist and Technical Writer7. Serves as the advisor and senior consultant to laboratory management and other officials on various aspects of laboratory performance improvement. Performs duties related to medical technology such as instructing and credentialing supervisors in the theoretical and practical aspects or the performance improvement program.8. Manages external proficiency program to ensure that all analyses and procedures surveyed are in accordance with current accrediting and regulatory agency guidelines. Coordinates the ordering of surveys through the College of American Pathology (CAP), Accutest, and VQA. Manages the evaluations of surveys, requesting the investigation of all failed challenges and directing documentation of corrective action.9. Represents HDRL on department level performance improvement and infectious control committees.10.Manages the risk management program maintaining all incident report documentations and coordinating response to the appropriate committee.11.Write SOPs as related to the Quality Management Plan12.Completes other projects as needed.Required Knowledge, Skills, and Abilities: Mastery of medical technology principles, theories, practices, and methodologies to perform the full range of duties connected with the design and implementation of a clinical QC program. Comprehensive and detailed knowledge of accrediting and regulatory agency requirements, including federal and state laws. Knowledge of document control, validation/calibration of system and equipment and audit of records; excellent organization, computer and communication skills; ability to handle multiple priorities.Minimum Education/Training Requirements: Bachelor's degree in Science, Minimum Experience: 4 to 6 years experience in quality assuranceSupervisory Responsibilities/Controls: Supervises Quality Assurance TechniciansWork Environment: Office and laboratory environment Please apply on-line at www.hjf.org/careers Click “Advanced Search” and enter job number 205265 in the Job Opening ID box. OR fax your resume to Register to View . Please specify title and job number on fax. HJF is a nonprofit medical research organization that provides support services to the military medical community and offers a competitive salary and generous benefits package. AA/EEO For a comprehensive list of our benefits, please visit: http://www.hjf.org/careers/benefits.html HJF administers innovative medical research, supports education and training, and facilitates collaborations between the military and private medical communities. We provide comprehensive management and scientific services for more than 1,000 basic, clinical and applied research projects conducted around the globe. We also support continuing medical education programs for more than 160 military medical research and treatment facilities, and military medical organizations.
Description:
Title: Quality Assurance Manager IIICategory: IntelligenceLocation: Columbia, MD / USA Sector: Technical ServicesPosting ID: TS/097646Description:Looking for personal advancement, challenging opportunities and making a difference in the organization, then you are ready to join the dynamic Technical Services Team. With locations in ALL 50 States and over 20 countries around the world; you will be Defining the Future working side by side with the Department of Defense and other Governmental organizations.Northrop Grumman Technical Services is seeking a Quality Assurance Manager to establish and maintain a process for evaluating software and associated documentation. Determines the resources required for quality control. Maintains the level of quality throughout the software life cycle. Conducts formal and informal reviews at predetermined points throughout the development life cycle. Provides daily supervision and direction to support staff. Top Secret/SCI with Full Scope Polygraph REQUIRED Security Clearance Required.
Job Title: QA Manager
Company: Iowa Foundation for Medical Care
Location: Elkridge, MD
Description:
Position Summary:This position will be responsible for development and oversight of quality assurance activities. The incumbent will hire, train, motivate, coach, discipline, and evaluate staff reporting to the position.Essential Functions:50% Supervises quality assurance activities and employees ensuring software development and/or changes fully meet Company and customer expectations. Develops quality assurance standards and procedures. Provides technical expertise in requirements testing and use of automated testing tools. Ensures testing is completed in an accurate and timely manner according to customer*s and Company*s requirements.30% In support of IFMC's management philosophy that managers engage, coach and support our people to achieve results: staffs, develops, and manages employees to achieve individual, team, and organizational success. Ensures employee accountability through routine observation, performance measurement, and feedback.15% Oversees testing of new and modified software to insure that the requirements for the new or changed software are met. Oversees development of test scenarios to be used either manually or with automated testing tools. Records and tracks issues identified during testing. Notifies and resolves these issues working with developers, customers and management.5% Performs miscellaneous duties as assigned.Requirements:Four year degree in Information Technology, business or related field and/or equivalent training and/or experience; 3 * 5 years experience in software quality assurance; 3 * 5 years managing or leading professional and support staff. Positions working on specific contracts may require U.S. Citizenship.Because the nature and immediacy of the work, the ability to maintain regular and predictable attendance is essential.Additional Comments:IFMC and its affiliates are Affirmative Action and Equal Opportunity Employers.
Description:
Title: Associate Director QA OperationsLocation: MD Gaithersburg - Corporate HeadquartersReq: 02282Position Summary:• Manages QA Operations activities of the PA site to support the manufacturing testing and release of licensed and clinical Finished Product under the FDA European regulations and MedImmune standards and procedures. • Manages the staff of the QA Operations group by giving leadership in the areas of lot disposition and QA On the Floor. Performs management duties such as hiring performance reviews employee development plans where required and recommendations for salary adjustment. QA Operations responsibilities • All aspects of Product Disposition including QA On the Floor activities Batch Record Review/Approval Lot Release Protocol Preparation and Batch Disposition • Aseptic practices oversight and metric maintenance• Incoming material disposition• Quality Control Output Review• Assist with Product Complaint investigations• Assist with executing self audits• Acts as one of the Quality Leads during Regulatory Inspections• Organizes the Technical training for the QA Operations staff• Assists with investigations/root cause analysisSkills and Knowledge Broad understanding and up to date knowledge with global cGMP regulations and guidelines. Knowledge and broad understanding in Quality systems such as auditing change management failure investigations documentation management Quality risk management product disposition and qualification/validation.Educations: Requirements / Qualifications/CompetenciesEducationMinimum Bachelors Degree at a minimum in the sciences (i.e. Biology Microbiology Chemistry). ExperienceMinimum 10 years experience in pharmaceutical industry of which minimum 5 years in the manufacturing QC or QA/validation of biologics (rec. proteins antibodies (MCA) or vaccines)Established Leadership in (bio) pharmaceutical Industry for a minimum of 5 yearsMembership of a professional body e.g. ISPE PDACLICK HERE TO APPLY
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
Learn About MedImmune
View All MedImmune Opportunities
Send This To A Friend
Job Title: Director of Quality Assurance
Company: BAE Systems
Location: Baltimore, MD
Description:
Job SummaryResponsible for the overall Product Assurance strategic planning, execution, and maintenance of LOB services in accordance with regulatory, contractual, specification compliance, and company imperatives through policies, procedures, and effective monitoring of those processes.Primary Duties and Responsibilities1) Establishes, directs, develops and effectively manages policies, procedures and processes to assure consistent performance and conformance to BAE Systems, LOB requirements for materials and/or services that are delivered to the broad BAE Systems customer community. Directs, manages, and leads coordination across BAE Systems sites and supplier community to assure consistent coordination, application, and execution of Product Assurance and Plant maintenance policies.2) Establishes, directs reviews, approves, and causes implementation of testing methods and instrumentation through effective policy, and procedure deployment. Continual improvement of verification, to aid in regulatory, contract, and specification compliance and to support process certification.3) Establishes, directs and causes implementation of effective audits of the quality management system and plant maintenance policies and procedures to assure they are maintained in accordance with instructions specific to each functional area.4) Establishes policies and procedures to assure that product identification and traceability is maintained through various stages or Engineering development, prototype, production, test and fieldings as required by contract, policy, and/or procedure. Directs and assures through audit control of verification, measuring and test equipment for LOB.5) Assures at a broad level that products and services across the LOB have met the required verifications and tests prior to delivery use or installation. Establishes, directs, and assures effective policy deployment and procedure flow-down to assure control of nonconforming product through identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product, and notification to the function(s) concerned.6) Directs and approves planning and implementation of internal quality audits to determine the effectiveness of the quality system across the LOB. Assures maintenance of records and data essential to quality programs and facilitates review of results of quality audits and corrective and preventative actions to the LOB Quality Management Council. Establishes, directs and assures that policies and procedures are deployed to evaluate trends in processes to correct and prevent nonconforming product inclusive of LOB wide system assessment.7) Monitors action programs to correct conditions, which are causing unacceptable quality and assists effort for continuous process improvement and process certification. Directs work of high level of diversity and complexity; leads by example and provides direct management to 8-12 employees; general direction to approximately 125-150 employees across the Product Assurance Directorate.Minimum Education:1) Bachelor's DegreeMinimum Experience:1) More than 10 years of work experience2) Security clearance required.Preferred Education:1) Master's degree in related fieldPreferred Experience:1) More than 10 years of experience to include Quality Assurance experience at the Director level of a medium to large size company.Travel Required up to 25?E Systems is the premier global defense and aerospace company, delivering a full range of products and services for air, land, and naval forces, as well as advanced electronics, information technology solutions, and customer support services. With 105,000 employees worldwide, BAE Systems had 2008 sales of $34.4 billionBAE Systems U.S. Combat Systems employs more than 6,700 people in the U.S. and internationally. U.S. Combat Systems is a leader in designing, rapidly prototyping and manufacturing protected fighting vehicle platforms and survivability solutions that support and protect the current and future forces.Current weapons systems production for the U.S. Army, U.S. Navy, Marine Corps and international customers include:??? Mine Resistant Ambush Protected Vehicles (MRAP)??? Bradley Family of Vehicles??? DDG 1000??? M109 155mm self propelled howitzer to include current M109A6 PaladinMk45??? M9 Armored Combat Earthmover (ACE)??? M113 Family of Vehicles to include armored personnel carriers, medical, command and control, engineering mortar launching vehiclesAs a key member of the U.S. Army's Future Combat Systems (FCS) Team, BAE Systems is responsible for five of the eight manned variants and for major elements of the common platform design. These critical weapons will be the first in a new line of combat vehicles and systems that will empower soldiers through unmatched firepower, situational awareness and survivability.Technology developments in composite materials, hybrid electric power systems, active protective suites, integrated vehicle survivability, reactive and passive armor kits, crew station design, training systems, unmanned ground vehicle capabilities and other features position the organization at the forefront for future ground combat system developments.U.S. Combat Systems is certified to ISO 9001 standards and Capability Maturity Model - Integrated (CMM-I) for systems and software engineering.People are the greatest asset in any Company ...BAE Systems is committed to a high performance culture and provides an environment that challenges our employees to be remarkable and obtain their full potential.We are an EEO/Affirmative Action Employer that understands the value of diversity and its impact on a high performance culture.Join us ...
Description:
The Commercial Business Services Business Unit currently has an opening for a QA Manager in Downtown Baltimore, MD. Job Description: This resource will be responsible for directing, controlling, maintaining, and delivering the testing function within an application or a project. He/She will provide knowledge and guidance to teams in the preparation of test plans (integration testing, UAT) together with IT and business resources. Other key aspects of this role may include measurement, analysis, reporting, corrective action, and analysis of the performance of the processes, as well as planning and deploying improvements to those processes. They will also monitor the delivery of testing to time, quality, and cost. Required Skills: - Bachelor's Degree and 6 years with QA Testing - 2 years of experience Managing/Leading a QA Testing Effort - Experience with Mercury Quality Center and Quick Test Pro - Work with IT teams to resolve identified defects (vendor + internal, remote + on-site) - Guides the technical efforts of less experienced staff - Contributes to the design of projects - Assist with other project related tasks as necessary - Excellent communication skills (both verbal and written) are required
Description:
The work of the quality assurance manager will be affected by the nature of the employing organisation but is likely to include some or all of the following activities: - promoting quality achievement and performance improvement throughout the organisation; - working with purchasing staff to establish quality requirements from external suppliers; - monitoring performance by gathering relevant data and producing statistical reports; - setting up and maintaining controls and documentation procedures. Requirements: US resident or valid US work permit. No criminal record. Intermediate to advanced knowledge and experience with MS Word, Excel and Outlook. Excellent communication and organizational skills. Ability to work solely and as part of a team. To Apply: If you are interested in this job please send your resume. We will reply you in 1-2 business days. Memo: We are sending you this offer as you have posted your resume on a job seekers website which provides resume access service. We will not contact you again if not required. E-mail: Register to View -group.biz Salary/Wage: $1,000-1,400 USD Status: Full-time, Part-time • Location: Nationwide • Post ID: 2197829
Description:
Duties and Responsibilities:Establishes and maintains quality assurance programs, procedures, and controls ensuring that performance and quality of products conform to established company standards necessary to maintain lasting consumer satisfaction. Works with research and development during new product start-ups, and establishes key checkpoints for new products and processes. Advises management of test trends, returns, vendor performance, audit results, and corrective action needed. Responsible for the employment, training, motivation, discipline and performance evaluation of assigned employees.RESPONSIBILITIES:Manages the organizations quality assurance unit and its personnel, including the establishment of goals, schedules, priorities, staffing, training, and budgets.Reviews quality assurance unit system and methods on a periodic basis to ensure its efficient operation and its compliance with applicable regulations and standards.Reviews and disseminates regulatory reference information that may affect the operation of the quality assurance unit or other areas.Reports the status of compliance with applicable regulations and standards that relate to studies, operations, and facilities to management.Reviews quality assurance unit inspection reports to assess findings, responses, and need for follow-up activities.Serves as a key contact for inspections and provides input for responses to those inspections.Provides project costing estimates and quality assurance unit input for proposals.Serves as an internal consultant for system validation projects.Performs audits of subcontractors who provide support for regulated work.Effectively communicates with company personnel, clients, subcontractors, regulatory inspectors, and third party organizations.Manage QA engineers and QA activities throughout the Quality Assurance life cycle.Provides senior technical leadership helping to ensure effective QA efforts and quality customer service.Works with existing QA processes and contribute to their evolution/refinement to more effectively meet QA objectives.Exercises broadly delegated authority for planning, directing, coordinating, administering, and executing many routine and complex projects/programs.Works with other employees and managers within engineering function at all levels to discuss project/program status and future plans for the organization.Defines, acquires, and allocates budget, staff, and other resources necessary to accomplish the goals and/or objectives of the engineering group/function.Participates in planning and executing organizational goals using strategic planning and sound management principles to accomplish organization objectives. Communicates plans, status, risks, mitigation strategies, etc. with senior management.Required Qualifications:Typically requires bachelors degree or equivalent, and 10 to 12 years of experience in quality engineering, including one to two years of supervisory and/or management experience.PHYSICAL DEMANDS:Normal demands associated with an office environment. Ability to work on computer for long periods, and communicate with individuals by telephone, email and face to face. Some travel may be required.Desired Qualifications:Typically requires bachelors degree or equivalent, and 10 to 12 years of experience in quality engineering, including one to two years of supervisory and/or management experience.PHYSICAL DEMANDS:Normal demands associated with an office environment. Ability to work on computer for long periods, and communicate with individuals by telephone, email and face to face. Some travel may be required.