Lead QA Specialist - Warehouse

LonzaTampa, FL
1dOnsite

About The Position

Join our QA Operations team and play a key role in ensuring the highest standards of quality for our manufacturing and packaging operations. In this role, you’ll be directly connected to the shop floor, supporting teams, influencing quality processes, and contributing to the reliability of life‑changing products. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. Opportunities to develop leadership capabilities and advance within QA.

Requirements

  • 3 years of experience in manufacturing operations, laboratory operations, or Quality Assurance—ideally in the pharmaceutical or biotech industry.
  • Strong understanding of GMP, QA principles, and FDA regulations.
  • Ability to review, write, and approve technical documents with accuracy and attention to detail.
  • Experience participating in investigations, root‑cause analysis, and corrective/preventive action processes.
  • Demonstrated leadership skills with the ability to coach and oversee QA personnel.
  • Strong communication, decision‑making, and problem‑solving abilities.
  • High school diploma required; Bachelor’s degree preferred.

Responsibilities

  • Provide active, on-the-floor QA support to GMP manufacturing and packaging operations, ensuring quality compliance in real time.
  • Review SOPs, batch records, test methods, logbooks, and other GMP documentation to verify accuracy and adherence to approved procedures.
  • Independently write and approve SOPs, Master Batch Records, and CAPA documentation.
  • Participate in investigations, root-cause analysis, and risk assessments related to deviations and product quality impact.
  • Lead, coach, and develop a team of QA Operations personnel.
  • Assess potential product quality impacts during lot release and recommend improvements to processes and programs.
  • Support additional QA-related assignments while upholding all safety and sustainability expectations.

Benefits

  • Medical, dental and vision insurance.
  • Compensation programs that recognize high performance.
  • An inclusive and ethical workplace.
  • An agile career and dynamic working culture.
  • Opportunities to develop leadership capabilities and advance within QA.
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