Job Description

3 days ago Be among the first 25 applicants

TalentBurst, an Inc 5000 company provided pay range

This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

$30.00/hr - $40.00/hr

Duration: 12+ Months Contract

Schedule:

• Alternate Saturday, Sunday Tuesday, 06:00 PM 07:00 AM

Job Description:

Education and Experience:

• B.S. in scientific discipline or equivalent work experience.
• Prior batch record execution or review experience.
• Prior experience in investigation, change control, and other Quality Management Systems (QMS).
• Working knowledge of cGMPs.
• Excellent written and verbal communication and interpersonal skills.
• Strong analytical and problem-solving skills.
• Manufacturing and Manufacturing Sciences experience preferred.

Key Responsibilities:

• Provide on-the-floor QA oversight and support to manufacturing operations.
• Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations.
• Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations.
• Represent QA in support of deviations including active participation in Root Cause Analysis (RCA).
• Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel.
• Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies.
• Perform area walkthroughs.
• Perform other duties and projects as assigned by management.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Science, Research, and Engineering

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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