Quality Assurance Associate

TalentBurst, an Inc 5000 company; Novato (CA); On-site; USD 41,328 - 55,104; Full time

Job summary

An established industry player in pharmaceutical manufacturing seeks a dedicated QA professional to provide on-the-floor oversight and ensure compliance with quality standards. In this role, you will engage with manufacturing operations, review batch records, and respond to quality incidents, ensuring adherence to cGMP expectations. This is an exciting opportunity to contribute to high-stakes projects in a dynamic environment, where your expertise will directly impact product quality and safety. Join a team that values your skills and offers a contract position with a competitive pay range.

Qualifications

• B.S. in scientific discipline or equivalent work experience required.
• Prior experience in Quality Management Systems and cGMPs preferred.

Responsibilities

• Provide QA oversight and support to manufacturing operations.
• Review executed batch records to ensure compliance with procedures.
• Respond to quality-related incidents and perform investigations.

Skills

Analytical Skills

Problem-Solving Skills

Excellent Communication

Quality Management Systems (QMS)

Education

B.S. in Scientific Discipline

Equivalent Work Experience

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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