Sr. QC Associate

Position Title: Sr. QC Associate
Work Location: Fremont, CA 94555
Assignment Duration: 12 Months
Work Schedule: 1st Shift: Mon-Fri, 8AM-5PM
Work Arrangement: Onsite

Position Summary:

• The SR QC Associate is assigned to QC functional or technical area in either HPLC/CE, 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).

Background & Context:

• This role performs duties under limited supervision and according to standard operating and QC procedures in a multi-product facility.

Key Responsibilities:

• 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.

Qualification & Experience:

• 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.
• 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, Bachelor's Degree in a science or engineering related field with two (2) or more years of experience in cGMP regulated industry or equivalent.