Quality System Specialist II

Quality System Specialist II – Contract – San Francisco, CA – $24.00-$26.00/ 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 Bio - Pharmaceutical Company is seeking a Quality System Specialist II in San Francisco, CA .

Role Description

• Conducts a comprehensive and critical evaluation of Laboratory records including but not limited to content, results, data accuracy and scientific relevance, format and adherence to GMP.
• Performs a thorough review of raw data and documentation to ensure compliance to applicable specifications and protocols.
• Supports the laboratory testing group instrument qualification and method validation review.
• Performs procedural and method revisions, where necessary.
• Conducts GMP review of laboratory notebooks, logbooks and associated forms including electronic raw data to ensure compliance with our integrity policy.
• Supports OOS/OOT investigation and CAPA implementation
• Conducts off hour (early morning/late night/weekends) data review to support production needs.
• Provides new hire training.

Skills & Requirements

• Advanced knowledge of current Good Manufacturing Practices (GMPs), pharmacopeia and compendial requirements, and pharmaceutical industry practices.
• Strong knowledge of regulatory requirements surrounding Data Integrity.
• Familiarity of analytic testing methods and validation including laboratory instrumentation.
• Ability to apply critical thinking and good judgment.
• Strong organizational and problem solving skills.
• Strong verbal, written, and interpersonal skills are required.
• Proficiency in Microsoft Office and laboratory computerized systems such as Empower and LIMS.

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. #1142674


Job Type
Technology & Internet Services
$24.00-$26.00/ Hr.

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