QA Specialist

QA Specialist – Contract – San Francisco, CA – $30.00-$32.00/ 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 QA Specialist in San Francisco, CA.

Role Description

• Performs a variety of activities to ensure compliance with applicable regulatory requirements.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support.
• Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• May conduct or serve as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
• Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
• Interfaces with contract manufacturers and suppliers to address documentation and compliance issues.
• Normally receives general instruction on routine work, detailed instructions on new assignments.
• Knowledge Must have an understanding and application of QA principles, concepts, industry practices, and standards.
• Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
• With guidance exercises judgment within well-defined and established procedures and practices to determine appropriate action.
• Normally receives no instruction on routine work, general instructions on new assignments.
• Strong verbal, technical writing, time management and interpersonal skills are required.

Skills & Requirements

• Investigate and write investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology.
• Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
• Must have strong writing skills to present findings in a clear and concise manner.
• Must be detail-oriented and able to demonstrate a high standard of integrity.
• Must have a desire to demonstrate excellence by setting high standards.
• BS/BA degree and a minimum of 2-3 years of relevant experience. QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).

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. #1142688

Summary

Job Type
Contract
Industry
Technology & Internet Services
Location
California
Specialism
Other/TBC
Pay
$30.00-$32.00/ Hr.
Ref:
1142688

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