QA Specialist

QA Specialist – Contract – Foster City, CA - $50.00-$53.00/hr
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Biotechnology Company is seeking a QA Specialist in Foster City, CA.

Role Description

Provide QA review of cGMP equipment and instrumentation required to support manufacturing and testing at the NJ site. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of equipment records complies with all applicable regulations and guidelines.

• Provide Quality oversight of Equipment decommissioning activities.
• Provide Quality oversight of equipment Calibration and Preventive Maintenance Programs and activities related to decommissioning of Equipment.
• Assist in dispositioning of raw materials which will be moved or sent for destruction.
• Performs daily walkthroughs of facilities and inspects QC labs for general GMP.
• Monitors Environmental Monitoring System once per day.
• Review of logbooks to ensure compliance.
• Ensure functional areas perform self-inspection checklists once per week, including Facilities, Security and QC labs.
• Responsible for managing the review/approval of decommissioning documentation. retirement protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.
• Implements and ensures adherence of appropriate regulations and quality standards.
• Supports operations to encourage a Quality Culture and ensure a safe working environment.
• Provides training to QA personnel where appropriate

Skills & Requirements

• Excellent written and verbal communication skills required, including Responsible Business Communication.
• Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
• Must be proficient with MS Office applications.
• BS/BA in (U.S. or foreign equivalent) in Microbiology, Biology, Chemistry, Biotechnology, Biopharmaceuticals or related field.
• 3-5 years of experience in a Pharmaceuticals environment.
• Experience in equipment qualification, IT systems, automation, operations and manufacturing within the biotechnology/pharma industry and in new manufacturing facility environment is a plus.
• Practice knowledge and understanding of cGMPs.
• Biologics QC (Analytical and Microbiology) experience.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information. #1140308


Job Type
Technology & Internet Services
Foster City

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