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Sr. QC Associate
Job Location:
Job Location:
Fremont, CA - USA
Hourly Salary:
USD 38 - 39
Hourly Salary:
Posted:
23 October 2026 (12 hours ago)
Posted:
Application Deadline:
20 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Duties:
Skills:
Education:
Schedule Notes:1st Shift: Mon-Fri 8AM-5PM
- The SR QC Associate is assigned to QC functional or technical area in either HPLC/Client Potency testing (Bioassay and Binding assays) Residual Impurities Physicochemical/Drug Product Microbiology/Environmental monitoring Raw Materials/Cleaning validation/verification and Packaging testing.
- This role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility as well as executes and coordinates Raw Material sampling and testing and sampling of clean rooms (as applicable).
- The SR QC Associate coordinates routine-maintained activities and is responsible for routine quality and compliance activities (authoring of test methods specs plans reports forms SOPs).
- This role performs duties under limited supervision and according to standard operating and QC procedures.
- Trains other associates and technicians on methods and processes.
- Executes independently with adequate training three to five (3-5) analytical testing methods with different analytical principles under minimum oversight by qualified staff.
- Manages and reviews fundamental tasks such as but not limited to buffer prep TCU maintenance and cleaning.
- Identifies and implements fundamental improvements to lab processes compliance activities.
- Responsible for routine quality and compliance activities (authoring of test methods forms SOPs).
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
- Reports abnormalities and deviations in a timely and accurate manner.
- Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
- Maintains and improves lab areas according to predefined standards (5s).
- Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
- Conduct group training on compliance topics and scientific principles as needed.
- Performs testing and review within several different analytical technologies.
- Reviews and trends analytical data and compliance processes to identify out of trends.
- Authors routine compliance documents.
- Identifies process anomalies and areas for improvement for operations.
- Provides compliant and smart solutions for moderately complex methods and testing issues.
- Coordinates work within the team and cross functionally.
- Reviews data and identifies discrepancies and ensures they are properly investigated assessed and appropriate root causes are put in place.
- Represents team in matrix team meetings with cross functional team members to resolve issues and produce solutions.
- Trains other associates and technicians on methods and compliance.
Skills:
- Previous QC Experience preferred.
- Experience with performing analytical methodologies within different scientific principles relevant to Biopharmaceutical manufacturing.
- Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first-time mindset.
- Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
- Proven experience with technical review analysis and interpretation of scientific data.
- Strong written and verbal communication skills.
- Experience with computer-based systems and ideally experience with process control systems
- Previous experience reading and understanding SOPs and/or methods and document work in a written format applying cGMP/GDP standards.
- Ability to work as part of a high performing team and collaborate effectively with staff.
- Proficiency in 3-5 analytical methodologies within different scientific principles including technical review interpretation and trending as needed.
- Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals.
- Strong focus on execution of non-routine analytical methods or processes.
- Strong technical knowledge in analytical methods.
- Ability to work independently with very little supervision.
- Champions problem resolution.
- Knows when to escalate to line management.
- Strong technical knowledge in analytical methods.
- Work independently with very little supervision champions problem resolution knows when to escalate to line management and provides compliant and smart solutions for moderately complex method and testing issues.
Education:
- High School Diploma with six (6) years of experience in cGMP regulated industry or equivalent.
- OR Associate Degree with four (4) years of experience in cGMP regulated industry or equivalent.
- OR Bachelors Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent.
Schedule Notes:1st Shift: Mon-Fri 8AM-5PM
Required Experience:
Senior IC
About Company
LanceSoft is a global workforce solutions company connecting businesses with top talent across industries and geographies.
