Overview

Quality Assurance Associate Jobs in Novato, CA at TalentBurst, an Inc 5000 company

Title: Quality Assurance Associate

Company: TalentBurst, an Inc 5000 company

Location: Novato, CA

Position: Associate, QA Frontline, Req#: 35942720

Location: Novato, CA (100% onsite)

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, other Quality Management Systems (QMS)

Working knowledge of cGMPs

Excellent written and verbal communication and interpersonal skills

Must display 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

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