Senior Plant QA Specialist — Biotech GMP

Us Tech Solutions

Holly Springs (NC)

On-site

USD 90,000 - 130,000

Full time

3 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

US Tech Solutions is seeking a Sr. Associate Plant Quality Assurance (PQA) on-the-floor to partner with plant manufacturing and support groups for bulk drug substance production and new product introductions.

You will drive real-time decision making to ensure GMP quality requirements, providing coaching and direction for manufacturing events, deviations, and quality systems. This role emphasizes collaboration between Manufacturing and Quality staff, overseeing deviations, CAPAs, and change

Qualifications

Must have strong knowledge of cGMP and GDP in a biotech manufacturing setting.
Experience working in regulated environments with Quality Assurance oversight.
Understanding of upstream and/or downstream biotechnology processes.

Responsibilities

Provide ongoing quality oversight to ensure CGMP/GDP compliance across manufacturing, testing, storage, and distribution.
Drive closure of deviations, investigations, CAPAs, change controls, and validation records.
Ensure production/testing records are complete and properly documented.
Oversee on-the-floor analytical testing and advise on quality system improvements.
Identify and implement continuous improvement opportunities within processes and systems.
Support audits/inspections and interact with regulators during on-site reviews.