QC Associate III
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a QC Associate III to be part of our client’ s team in Fremont. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
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, problem-solves, and reports aberrant results to management. Includes but not limited to:
- Pulling and aliquoting raw material samples and distributing to the appropriate laboratories
- AQL inspection (e.g., visual defects, dimension testing, and all required attributes
- Ships samples to appropriate testing laboratories and prepares paperwork for testing.
- On call coverage for urgent samples.
- Ensures sample integrity is intact, paperwork is completed and correct and LIMS entries are performed.
- Ensures timelines are met.
- Follows well-defined and established procedures and best practices.
- Reviews QC test results
- Generates, reviews and/or maintains records or documents in a detailed and consistent manner (e.g., sample summary form, test records, retain sample forms, etc.).
- Prepares sample reconciliation reports and other reports as needed.
- Assists with QC' s data management, including data review and trending.
- 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.
- Performs an Owner role for Change Controls and Deviations
- Independently writes and/or updates raw material specifications and reports.
- Responsible for ensuring all raw material documentation and reports are reviewed and are in accordance with the raw material specifications.
- Generates, reviews and/or maintains records or documents in a detailed and consistent manner.
- Prepares sample reconciliation reports, periodic trend reports, generate metrics and other reports as needed. Reviews and reconciles reports with internally produced data. Maintains raw material released data lot packets and reports, creates raw material final reports.
- Process improvement and compliance:
- Revises standard operating procedures, training manuals, etc. which are submitted to management for review and final approval.
- Ensures equipment calibration and preventive maintenance are up-to-date
- Maintains specific QC files and database records for process and/or quality improvement efforts.
- Pro-actively reviews and develops new raw material specifications, standard operating procedures, protocols etc. to ensure BI stays at the forefront of quality control practices.
- Enters data in databases as appropriate.
- Performs an Owner role for Change Controls and Deviations.
- Maintain laboratory cleanliness and orderliness.
- Works with SQM and Quality Compliance on material qualification.
- Review raw material lot packets to ensure appropriate samples are taken and tested according to specification.
- Monitors material testing and release status and turnaround times.
- Cross-train in other RM duties to cover for other RM members when needed.
Summary of Qualifications:
- Bachelors’ degree in a Scientific Discipline.
- In depth experience in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals
- 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
- Physical Demands / Surroundings:
- 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.
- Must be able to read electronic documents of all types.
- Hearing acuity required.