Sr. QC Associate

VARITE • Fremont, CA

1d • Onsite

About The Position

The Sr. QC Associate works in an assigned Quality Control functional or technical area, such as HPLC/CE, potency testing, residual impurities, physicochemical or drug product testing, microbiology or environmental monitoring, raw materials, cleaning validation or verification, and packaging testing. The role executes and coordinates analytical testing of bulk drug substances and drug products in a multi-product facility, as well as raw material sampling and testing and cleanroom sampling, where applicable.

Working under limited supervision and established operating and QC procedures, the associate performs routine quality and compliance activities, including authoring test methods, specifications, plans, reports, forms, and SOPs. The associate independently executes three to five analytical methods based on different scientific principles after adequate training, reviews and trends analytical data, addresses discrepancies and anomalies, and provides compliant solutions to moderately complex testing issues. The role also coordinates work across teams, represents the QC team in cross-functional meetings, and trains associates and technicians on methods, processes, and compliance topics.

The position is onsite in Fremont, California, and is a 12-month contract with possible extension. The stated pay range is $38.74–$41.51 per hour on W-2.

Requirements

• High school diploma and six years of experience in a cGMP-regulated industry or equivalent; or an associate degree and four years of such experience or equivalent; or a bachelor's degree in a science- or engineering-related field and at least two years of such experience or equivalent.
• Proficiency in three to five analytical methodologies based on different scientific principles, including technical review, interpretation, and trending as needed.
• Strong understanding of analytical chemistry and/or analytical testing as applied to biopharmaceuticals.
• Proven experience with technical review, analysis, and interpretation of scientific data.
• Ability to perform detail-oriented work in a complex technical environment with a quality-focused, right-first-time mindset.
• Strong written and verbal communication skills.
• Ability to work independently with little supervision, champion problem resolution, and recognize when to escalate issues.
• Ability to collaborate effectively as part of a high-performing team.
• Ability to focus on execution of non-routine analytical methods or processes.
• Experience reading and understanding SOPs and/or methods and documenting work in writing according to cGMP/GDP standards.

Nice To Haves

• Previous QC experience.
• Experience with computer-based systems; experience with process control systems is desirable.

Responsibilities

• Execute and coordinate analytical testing of bulk drug substances and drug products in a multi-product facility.
• Execute and coordinate raw material sampling and testing and cleanroom sampling, as applicable.
• Perform testing and review using several analytical technologies, independently executing three to five methods based on different scientific principles after adequate training.
• Coordinate routine maintenance activities and manage fundamental tasks such as buffer preparation, TCU maintenance, and cleaning.
• Author routine quality and compliance documents, including test methods, specifications, plans, reports, forms, and SOPs.
• Document work according to cGMP and cGDP, follow site regulations and procedures, and report abnormalities and deviations promptly and accurately.
• Review and trend analytical data and compliance processes to identify out-of-trend results, discrepancies, and process anomalies.
• Ensure discrepancies are investigated and assessed appropriately, with suitable root causes established.
• Identify and implement fundamental improvements to laboratory processes and compliance activities.
• Maintain laboratory areas according to predefined 5S standards and adhere to safety standards, escalating unsafe situations as appropriate.
• Maintain required training compliance and train associates and technicians on methods, operations, processes, and compliance topics after qualifying as a trainer.
• Coordinate work within the team and across functions, and represent the team in matrix meetings to resolve issues and develop solutions.
• Resolve moderately complex method and testing issues with compliant, practical solutions, and escalate issues to line management when appropriate.

Benefits

• Medical, dental, and vision coverage for eligible employees.
• Participation in a company-sponsored retirement savings plan.
• Legal service plans providing access to attorneys for advice and representation.
• Employee referral bonus eligibility if a referred candidate is hired.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED