An innovative biotech company in the Greater Boston area is looking for a qualified QA Specialist. The company is a full-service nonclinical CRO developing innovative services and solutions for the pharmaceutical, biotech, medical device and regenerative medicine industry. With a research and testing team for small molecules, large molecules, biologics, medical device and cell and gene therapy products, this role would be ideal for a QA professional looking to advance in his/her career, develop new skills within a collaborative team environment, or to add a reputable workplace to their resume.
- Perform disposition of batches, including resolution of investigations and deviations.
- Conduct manufacturing and packaging batch record reviews.
- Perform document control activities in order to ensure compliance within the controlled document management system both electronically and manually.
- Maintain batch related documentation including but not limited to issuance and maintenance of batch records, labels, logbooks, spreadsheet tracking logs.
- Compile Product Quality Reports (e.g. annual product reports, batch review summary report).
- Support partner audits through gathering and collating of quality metric data.
- Support quality investigations utilizing QA tools and follows up on corrective actions to closeout.
- Bachelor's degree in a scientific discipline is required. Equivalent experience may be accepted.
- 1-5 years' experience in the pharmaceutical industry within GMP regulated environment.
- Strong oral and written communication skills.
- Knowledge of FDA regulations and cGMPs of drugs.
- Highly detail-oriented.
- Ability to coordinate activities with multiple functional groups with sense of urgency.
- Ability to work with minimal supervision.
This is a contract-to-hire role; full benefits provided.