Senior Quality Control Associate

Job description

Senior Quality Control Associate, Carlsbad, CA

Great Sr. QC Associate opportunity with a growing biopharmaceutical in North County San Diego.

• Manage incoming inspection of raw materials in accordance with company policy and procedures
• Participate in environmental monitoring for the facility on a routine basis per applicable SOPs including sampling of the USP Purified Water system
• Manage deviation/OOS investigations and implement CAPAs and change controls per GMP requirements
• Author and revise QC related SOPs as required
• Participate in the review and approval of Manufacturing Batch Records for QC related activities
• Execute analytical method transfer activities, including product-specific test methods
• Train junior personnel in appropriate laboratory and safety procedures
• Execute Installation and Operational Qualification of analytical instrumentation where applicable

Education/Qualifications

• Undergraduate degree (B.A. or B.S.) in a Life Science discipline
• 5+ years GMP experience in a Quality Control function within the medical device and/or biopharmaceutical fields
• A high level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
• Analytical experience in the following methodologies: Buffer Characterization (pH, conductivity, osmolality), Concentration (UV/Vis and/or Fluorescence), Chromatography (HPLC, Electrophoresis)

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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