Quality Assistant Jobs in Massachusetts

Job Title: Quality Associate Director Company: Genzyme Location: Framingham, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme's people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune's list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzyme's local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.Quality Assurance Associate DirectorThis position will provide Quality Assurance guidance for a new multi product cell culture production facility from Integrated Commissioning and Validation (ICV), start up to licensure to full scale production. This position will manage a staff of QA professionals on multiple shifts.This individual will report to the Sr. Director of QA/QC at the Framingham site and will be responsible for providing leadership and technical management of the Quality Assurance group. The position will have 2 direct reports with a total organization of approximately 25 people. The primary responsibilities of the groups include assuring that efficient processes are in place to meet bulk and finished product lot testing and release schedules, and maintaining effective quality systems and practices to ensure regulatory compliance. The scope of manufacturing operations at the various sites includes buffer and media preparation, cell culture and purification.Major responsibilities include:•Providing management and technical input into the design, development and establishment of manufacturing and operations at a soon to be constructed 150,000 square foot facility housing additional cell culture, purification, laboratory and other support functions.•Identifying quality improvement opportunities within operations and partnering with peers in Manufacturing and Quality Ops at the Allston site to develop and implement solutions. Evaluate, propose and implement new processes and technologies as alternatives to optimize efficiencies in the departments.•Developing and managing departmental budgets in cooperation with direct staff.•Supporting an environment of staff development and learning. Providing feedback to direct reports in a timely manner. Managing performance issues and soliciting the appropriate input from HR and management. Writing and administering performance appraisals on time and in a thorough and thoughtful manner.•Developing and executing hiring plans. Ensuring that requisitions are interviewed for and filled in a timely manner.•Keeping senior management apprised of product issues, dispositions and quality improvement plans.•Providing oversight of regulatory agencies during site inspections.•Reviewing and revising standard operating procedures where appropriate.•Developing a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations.Extensive knowledge of fundamentals in the Biotechnology/Pharmaceutical fields and hands on technical expertise is required. Comprehensive knowledge of FDA and EMEA regulations and experience in US and international regulatory agency audits and inspections of the biopharmaceutical industry, including, but not limited, to aseptic processing of biologics is essential. Excellent technical writing skills are necessary as well as a working knowledge of statistical analysis, process, software and method validations. Familiarity with Trackwise, Indysoft, MES and/or Catsweb is desirable. Experience with facility start up required and ICV preferred.

Job Title: QUALITY ASSURANCE ASST Company: GORTONS Location: Gloucester, MA Description: Quality Assurance Gorton's, America's leader in frozen seafood since 1849, has positions within our processing facility as well as our inspection laboratory. Positions are available for 1st, 2nd and 3rd Shift as well as weekend work. Gorton's offers the entrepreneurial spirit of a smaller organization, along with the resources of a leader in consumer products. This is a non-exempt position. Responsibilities include: -Conduct detailed examination of raw materials and finished goods, and maintain records of examinations on PC. -Ensure Compliance with Gorton's U.S. and global food safety standards. -Inspection for proper sanitation of production lines and ensure standard operating procedures. -Assist with HACCP document review process. Qualifications include: -Bachelor's in Business or Science and 3-5 years of experience in food quality and sanitation -HACCP Certification preferred ? Ability to work independently -Team Player -Demonstrated Leadership Skills -Demonstrated computer skills -Must be able to lift 60 lbs. -No fish allergies Candidates must have permanent work authorization in the U.S. Gorton's offers excellent growth potential, competitive pay and great benefits. Candidates should send their resume and cover letter to: Gorton's, 128 Rogers Street, Gloucester, MA 01930, or via e-mail in "Word" format to: Register to View Gorton's is an Equal Opportunity Employer