QUALITY ANALYST - GMP - PHARMACEUTICAL
- Responsible for implementing and coordinating the QA review function ensuring all quality documents including batch records, QC records, and Validation documents, are reviewed in a timely manner. The review function will also be responsible for generation of APR's, QA reports, and stability reports.
- Responsible for implementing and coordinating quality systems including CAPA, deviation, change control, work order systems, Training, DCC and supporting any DSO or Corporate driven initiatives to enhance these systems.
- Responsible for implementing and coordinating all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation. Identify and update appropriate procedures to assist in the management of QA system to ensure closure and approval.
- Integration, preparation and distribution and review of product documentation, master batch records, media holds etc. to support operations and quality control departments consistent with corporate objective, GMP, and regulatory requirements.
- Support the initiative in creating an embedded quality culture utilizing the following:
- Data driven decision making.
- Right First Time initiatives.
- Failure Mode Effect Analysis.
- Risk Assessment and HACCP Principles.
- Contributing to BSL improvement initiatives.
- BSL requires that each QA Specialist is proficient in multiple disciplines and areas including, Commercial life cycle phases at Client sites.
- BS degree in Biology, Biochemistry or a closely related science discipline.
- Technical: 4 to 7 years of QA systems experience within Biotech or Biopharmaceutical environment.
- MUST have GMP experience working in a biotech or bio pharmaceutical industry.
- MUST also have Quality Systems experience (Deviations, Change Controls, Work Orders), and familiarity with review of GMP documents and ability to write technical reports.
- IT Systems: Strong user of Track Wise, Microsoft Project, Excel.
- Regulatory: Prefer experience in a GMP regulated environment.
- Analytical: Prefer experience in protein chemistry.
This 24+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: firstname.lastname@example.org
ALPHA'S REQUIREMENT #19-01392
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE