Summary:
A cutting-edge clinical-stage biopharmaceutical company developing new drug candidates is looking to bring on a QA Specialist for a temporary contract assignment for its San Francisco location. The company supplies its technology to other pharmaceutical companies including Affymax, Amgen, Merck, Pfizer and UCB Pharma, and currently has a pipeline of new investigational drugs for treatments of cancer, auto-immune disease, and chronic pain. This role will be tasked with performing a wide variety of QA functions in the department including batch record reviews, document control, and quality investigations. This role would be ideal for a QA professional looking to get a foot in the door with a reputable brand, or to add an impressive workplace to their resume.
Responsibilities:
- 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.
Education:
- Bachelor's degree in a scientific discipline is required. Equivalent experience may be accepted.
- 2+ 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.
