QA Specialist, Operations - Warehouse

Lonza•Tampa, FL

2d•Onsite

About The Position

Join our Quality Assurance team and play a critical role in supporting GMP compliance, documentation accuracy, and audit readiness across manufacturing operations. This is an exciting opportunity to contribute directly to the quality and safety of products that impact millions of lives.

Requirements

Experience working in a cGMP‑regulated pharmaceutical, biotech, or related environment.
Strong skills in GMP documentation review, quality systems, and cross‑functional collaboration.
Ability to assess deviations, support investigations, and contribute to corrective and preventive actions.
High school diploma required.
Clear communication skills, attention to detail, and the ability to support audits and compliance activities.
A continuous‑improvement mindset and ability to work both independently and collaboratively.
3 years of relevant work experience required.

Nice To Haves

Familiarity with Track Wise, SAP, and Microsoft Office (preferred but not required).
Bachelor’s degree preferred.

Responsibilities

Review SOPs, batch records, test methods, protocols, deviations, CAPA, specifications, and logbooks to ensure all cGMP activities are documented accurately and in compliance with procedures.
Approve SOPs, Master Batch Records, executed batch records, and release laboratory data and reports.
Assess potential product quality impact for open deviations during lot release and participate in root‑cause investigations.
Support internal, vendor, and customer audits, including back‑room support during regulatory inspections; may also lead audits.
Collaborate with cross‑functional teams to troubleshoot issues and support alignment with department and company goals.
Attend client meetings and calls to provide QA support and ensure clarity on requirements.
Uphold all Safety and Sustainability expectations by reporting issues promptly and stopping work when needed to maintain safety.