Quality Control Associate III
6755 Kaiser Dr Fremont, CA 94555
Bayside Solutions is seeking a Quality Control Associate III to be part of our client’ s team in Fremont. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Quality Control Associate III
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Reviews raw material lot packages and releases RM lots for GMP manufacturing use.
- Ensures lot release timelines will be met and coordinates testing performed at in-house and contract laboratories.
- Prepares sample submission forms, performing necessary LIMS and SAP transactions, review of test records, tracking status of samples and their respective tests, etc.
- Tests/Inspects components per specification and specified methods.
- Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, material specifications, analytical investigations, and laboratory test plans and related technical reports.
- Ensure compliance with current regulations.
- Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
- Performs logbook and/or LIMS entries when using equipment/instruments.
- Reconciles samples.
- Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks.
- Assists with QC' s data management, including data review and trending.
- Maintains specific QC files and database records for process and/or quality improvement efforts.
- Maintain laboratory cleanliness and orderliness.
- Cross-train in other RM duties to cover for other RM members when needed.
- Bachelors’ degree in a Scientific Discipline
- In depth experience in a laboratory environment
- Six (6) years cGMP or appropriate experience required.
- Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards required.
- Strong technical writing required
- Knowledge of CFR, USP, and ICH required.
- Knowledge of SAP, Trackwise and LIMS desired.
- Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems
- Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet timelines.
- Demonstrated problem-detection and problem-resolution skills required