639 Granite Street, Suite LL25, Braintree, MA 02184
781.848.5500
781.848.5500
The Director / Senior Director, Quality Control (QC) is responsible for the leadership and organization of the Quality Control team. A key role of the Director will be to ensure that the QC function is operating efficiently and able to support applications for marketing approval and commercial supply.
The QC team is responsible for activities that include: raw materials testing, product testing, in-processing testing, stability testing and EM testing for air, surfaces, water systems, and air/gas distribution systems in support of Phase III production and commercial supply. The Director will ensure that this work is planned, performed and reported in an efficient and compliant manner. The Director will be responsible for all QC activities, focusing on areas related to batch review and product release testing to assure timely supply of product. The Director will also be responsible for technology transfer of QC assays and validation of test procedures / sites. Additional studies will also be required to be managed in support of regulatory submissions i.e. stability, comparability and characterization testing. The Director will provide technical expertise for laboratory investigations and follow through on close out actions. The Director will be responsible for ensuring all data reports and documentation to support regulatory submissions are available on schedule.
Requirements:B.A or B.S. degree in a relevant biological science and extended relevant commercial experience. M.S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred. A minimum of 10 years experience in a cGMP Quality environment and 5 years in a senior managerial role; or equivalent combination of education and experience. Thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations supporting clinical and commercial manufacturing, ideally including international experience. Proven leadership in managing and motivating team members to achieve QC goals. Ability to interface effectively with management and other groups, project teams and personnel at manufacturing site. Computer processing literacy and experience in statistical analysis. Excellent verbal and written communication skills and a track record of preparing documentation in support of regulatory submissions.
This position requires a minimum MS Degree in chemistry or equivalent plus at least 12 years laboratory experience in a biologics or pharmaceutical environment.
Strong knowledge of compendial requirements, ICH method validation principles, CGMP's/harmonized regulatory requirements, laboratory investigational tools and experience with presenting information to the FDA is requiredl. Requires strong project management and statistical analysis knowledge. Ability to work in a team environment ,facilitate a team approach and communicate effectively. Proven management and leadership skills with the ability to manage a multi-shift organization.
The Quality Control Associate – Microbiology is responsible for product testing, environmental monitoring, raw material testing, and general laboratory maintenance. Will perform in-process and final product sterility testing, air viable monitoring, particulate monitoring, purified water system testing, and surface sampling and growth promotion testing of raw materials. Must adhere to good documentation practices and ensure data traceability.
The Quality Control Manager will oversee the delivery of compliant laboratory data and will manage the Microbiology Laboratory operations on a daily basis and during FDA inspections. This role will oversee microbiological tests, monitor sample collection, testing, and data review, and will conduct and manage lab investigations, as well as working with Corporate Quality Control.
Managers)
Email recruiter Responsibilities:QC Bioassay personnel will be responsible for in-process, final product, and stability testing in Bioassay Laboratory (flow cytometry, ELISA, etc.) Manage key reagents, ensure laboratory data integrity and traceability, provide technical expertise during validation studies, responsible for data trending, assist with coordination of QC training, and participate in process improvement activities.
