Manufacturing Associate Job at TekWissen ® in Vacaville

Job Title: Manufacturing Associate

Location: Vacaville, CA - 95688

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Pay Range: $20 to $25 per hour

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Summary

With limited supervision, the QC Associate I is responsible for performing direct materials testing in compliance with cGMP regulations. The role involves executing laboratory testing, reviewing and trending data, supporting investigations (OOS, OOT, OOE), and contributing to laboratory operations and quality objectives. The position works closely with Quality Control leadership to meet departmental and organizational goals.

Responsibilities

• Perform basic to moderately complex laboratory testing in compliance with GMP requirements
• Review, analyze, and assess test data against established acceptance criteria
• Conduct technical review of peer-generated data
• Perform trend analysis and assist in establishing limits
• Identify discrepancies and support quality investigations and CAPA initiatives
• Troubleshoot technical and testing-related issues
• Identify gaps in systems, procedures, and laboratory practices
• Participate in assay transfer, assay validation, and method-related activities
• Perform equipment qualification, calibration, and routine maintenance
• Prepare and maintain standards, controls, stocks, cultures, and reagents per procedures
• Ensure GMP compliance across laboratory operations
• Support internal and external audits and regulatory inspections
• Coordinate with internal customers to support multi-site operations
• Meet assigned schedules, timelines, and deadlines (95% on-time performance expectation)
• Participate in or lead team projects, process improvements, and continuous improvement initiatives
• Write protocols, reports, and technical documentation under limited supervision
• Provide and receive training as required
• Perform additional duties as assigned to support Quality activities

Required Skills

• Bachelor’s degree (B.S./B.A.) in a relevant scientific discipline with 1–3 years of industry experience OR
• Master’s degree with at least 1 year of relevant experience
• Experience in the pharmaceutical or biopharmaceutical industry
• Hands-on experience with analytical and/or biological testing procedures
• Strong understanding of cGMP regulations and quality systems
• Experience with OOS, OOT, and OOE investigations
• Exposure to assay transfer, assay validation, and method lifecycle activities
• Experience supporting regulatory inspections (FDA, EMA, etc.)
• Familiarity with trend analysis and data integrity practices
• Prior involvement in process improvement or cross-functional projects
• Experience working in multi-site or global operational environments
• Ability to apply scientific principles, theories, and techniques in a QC environment
• Strong verbal and written communication skills
• Sound judgment, analytical thinking, and problem-solving abilities
• Ability to work independently with limited supervision and manage short-term priorities

TekWissen® Group is an equal opportunity employer supporting workforce diversity.