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Senior Quality Control Specialist (Biopharma)


This is a Contract position in Brisbane, CA posted October 27, 2020.

We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Specialist, Quality Assurance for a direct placement opportunity! The position reports to the Director, GMP Quality Assurance. The location of the position is in Brisbane, CA.

Summary Description

The Senior Specialist, Quality Assurance is accountable for independent approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. This person will also approve documentation accompanying the disposition of raw materials and components to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections, independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. Issue reports summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues/trends.

Primary Responsibilities

  • Act as Development Quality representative for in-house or outsourced manufacturing for clinical supplies. Duties include compliance oversight of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, change management approval, etc.
  • Accountable for all assigned projects and communication of status to the Management team.
  • Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist areas in SOP and quality-related system development and approval.
  • Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables.
  • Prioritize work for assigned projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality.
  • Assist preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations, including GMP Certification inspection.

Education Minimum Requirements

  • B.S. in appropriate Science or Engineering discipline (chemistry, biology biochemistry, microbiology); advanced degree preferred.

Required Experience And Skills

  • Minimum 5 years’ experience in Pharmaceutical or related industry.
  • Functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development .

About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we’ve grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.

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