Job Description

Kelly® Science & Clinical is seeking a Quality Assurance Specialist for a 6-month contract position at a leading biotech company in San Jose, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:

$35-40/hour

Overview :

In this role, you will oversee quality processes, participate in audits, assist with investigations, and review equipment documentation, all in a GMP manufacturing environment.

Schedule:

Monday-Friday, standard working hours

Responsibilities:

• Manage Quality Event programs such as Deviations, Investigations, CAPA, Complaints, etc.
• Participate in quality audits, including the timely preparation of audit reports.
• Prepare/assess quality audit findings with respect to required corrective actions, ensures timely reporting to the Senior Management team, and conducts follow-up.
• Assist with deviation investigations and the resolution of minor discrepancies relating to manufactured products and raw materials.
• Review equipment documentation such as activity logs, chart recorders, calibration records, IQ/OQ/PQ, etc.
• Develop, update, and/or review standard operating procedures, batch production records, etc.
• Other duties as assigned.

Qualifications:

• Bachelor's Degree in Life Science or equivalent
• 2+ years of direct QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry. Experience in cell-based therapeutics or biopharmaceuticals preferred .

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