Sr. QC Associate

Spectraforce Technologies

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.

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Vacancy posted more than 2 months ago

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