QA Specialist
Hays

Job Info

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 San Dimas, CA.

Role Description

• Performs a variety of activities to ensure compliance with applicable regulatory requirements.
• Performs on the floor QA Oversight and reviews for adherence to sites SOPs with emphasis on Data Integrity and computerized systems.
• Works on problems ranging from semi routine to moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Good judgement is required in resolving problems and making routine recommendations.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) and Data Integrity.
• Perform review of manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues and applicable computerized systems reviews.
• 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.
• Normally receives general instruction on routine work, detailed instructions on new assignments. Knowledge, Experience & Skills: Essential:
• Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates basic knowledge of FDA / EMEA standards and quality systems.
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates working knowledge in Microsoft Office applications.

Skills & Requirements

• Specific Education & Experience Requirements: 2+ years of relevant experience in a GMP environment related field and a BS. 3+ years of relevant experience and an AA degree.
• Prior experience in pharmaceutical industry is beneficial. Phone Screen and Zoom Interviews Required Medicals: Blood work (CBC, CMP, Lipid Profile) Urinalysis - Dipstick Physical - Non DOT History; Vision Test -( Ishihara, Jaeger, Snellen) Pulmonary Function Test (Spirometry)
• Prior experience in biologics preferred

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)

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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.
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