What are the responsibilities and job description for the Associate, QA Frontline position at Bayside Solutions?
Associate, QA Frontline
W2 Contract
Salary Range: $72,800 - $83,200 per year
Location: Novato, CA - Onsite Role
Job Summary:
As an Associate, QA Frontline, you will provide on-the-floor quality oversight and support manufacturing operations, ensuring compliance with cGMP and approved procedures through batch record reviews, real-time incident responses, and participation in root cause analysis. You will also guide manufacturing teams, support QMS documentation, and conduct area walkthroughs, among other projects. The schedule for this role is Wednesday, Thursday, and Saturday, from 6 am to 7 pm, and may change depending on operational demands.
Duties and 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 technical personnel.
- Provide QA support, including authoring, reviewing, and approval of documents in Quality Management Systems.
- Perform area walkthroughs
- Perform other duties and projects as assigned by management.
Requirements and Qualifications:
- 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
- Must display strong analytical and problem-solving skills
- Manufacturing and Manufacturing Sciences experience preferred
Desired Skills and Experience
QA Oversight, Batch Record Review, Incident Response, Root Cause Analysis, QMS, cGMP, Documentation, Compliance Guidance, Communication, Interpersonal Skills, Analytical Skills, Problem-Solving Skills, Manufacturing
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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Salary : $72,800 - $83,200
