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Lonza

QA Specialist, Operations - 12hr Day or Night Shift

Lonza Tampa, Florida, United States

Pharmaceutical Manufacturing · 10,001+ employees

Oct 21
qa Mid (2-5 yrs) Full-time United States
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About the role

The QA Specialist will review and approve documentation such as SOPs, batch records, and CAPA to ensure compliance with cGMP standards. They will also participate in investigations, audits, and cross-functional initiatives to support product quality and safety.

What they look for

Quality assurance cGMP compliance SOP review Batch record review CAPA Deviation assessment Regulatory inspections Auditing Trackwise SAP Microsoft Office Attention to detail Cross-functional collaboration Manufacturing processes Quality management systems

Requirements

Candidates must have a Bachelor’s degree in a Science or related field and proficient experience in quality assurance or manufacturing. Knowledge of Pharma cGMP standards and familiarity with Quality Management Systems like Trackwise or SAP are required.

Benefits

Performance-related bonus Medical insurance Dental insurance Vision insurance 401(k) matching plan Life insurance Short-term disability insurance Long-term disability insurance Employee assistance programs Paid time off

Full description

QA Specialist, Operations - 3rd shift

Shift: 12 Hour Shift

Location: Tampa, Florida, USA.

Join our team in Tampa, FL, where you’ll play a key role in ensuring compliance with cGMP standards and supporting quality assurance processes for manufacturing. This is an exciting opportunity to contribute to product quality and safety while collaborating across multiple departments.

What you will get

  • Performance-related bonus.
  • Medical, dental and vision insurance.
  • 401(k) matching plan.
  • Life insurance, as well as short-term and long-term disability insurance.
  • Employee assistance programs.
  • Paid time off (PTO).

What you will do

  • Review SOPs, batch records, test methods, protocols, deviations, CAPA, and related documentation to ensure compliance with cGMP standards.
  • Approve SOPs, Master Batch Records, executed batch records, and laboratory data reports.
  • Assess product quality impact for open deviations during lot release.
  • Participate in investigations, audits (internal, vendor, customer), and provide support during regulatory inspections.
  • Collaborate with cross-functional teams to resolve issues and achieve departmental goals.
  • Attend client meetings and calls to support quality initiatives.
  • Ensure adherence to safety and sustainability requirements, reporting and correcting issues promptly.

What we are looking for

  • Bachelor’s degree in a Science or related field required or equivalent experience.
  • Proficient experience in quality assurance or manufacturing required.
  • Knowledge of Pharma cGMP standards required.
  • Familiarity with Quality Management Systems such as Trackwise, SAP, and Microsoft Office tools.
  • Strong attention to detail and ability to work collaboratively across teams.
  • Experience in audits and regulatory compliance processes is advantageous.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

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