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 the East Bay. 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.
QC 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:
- Performs sampling/testing/inspection of raw materials, conducts lab investigations, and reports aberrant results to management. Includes, not limited to:
- Pulling and aliquoting raw material samples and distributing to the appropriate laboratories
- AQL inspection (e.g., visual defects, dimension testing, etc)
- Prepares paperwork and ships samples to appropriate testing laboratories.
- On call coverage for urgent samples.
- Data entry and reviews QC documentation (e.g., test results, data packets, etc.)
- Generates, reviews and/or maintains records or documents in a detailed and consistent manner (e.g., sample summary form, test records, etc.).
- Reconciles samples. Perform required reviews of appropriate forms (e.g., test records) and logbooks.
- Performs an Owner role for Change Controls and Deviations
- Prepares and reviews trend reports, generate metrics and other reports as needed. Maintains raw material data.
- Revises SOPs, training doc, etc.
- Ensures equipment calibration and preventive maintenance are up-to-date
- Performs an Owner role for Change Controls and Deviations.
- 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 time lines.
- Demonstrated problem-detection and problem-resolution skills required
- Lifting, carrying, pushing or pulling up to 50 pounds occasionally
- Frequent periods of sitting, walking, and standing
- Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
- Occasional low level work, fine finger dexterity/ including grasping or pinching required
- Writing and use of a computer keyboard frequently
- Occasional use of personal protective equipment
- Visual / Hearing Demands: Color vision and depth perception required. May require extended hours at a computer screen. Hearing acuity required.