QA Specialist, Operations - 12hr Day or Night Shift

Lonza • Tampa, FL

10d • Onsite

About The Position

The QA Specialist, Operations supports manufacturing quality assurance in Tampa, Florida, helping ensure compliance with cGMP standards and contributing to product quality and safety. The role works with multiple departments on quality processes and initiatives, including documentation review and approval, lot-release assessments, investigations, audits, and regulatory inspections. The position is listed as a 12-hour day or night shift, with a separate reference to 3rd shift.

Requirements

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

Nice To Haves

• Experience in audits and regulatory compliance processes.

Responsibilities

• Review SOPs, batch records, test methods, protocols, deviations, CAPA, and related documentation for cGMP compliance.
• 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 and internal, vendor, and customer audits; support 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, and promptly report and correct issues.

Benefits

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

What This Job Offers

• Job Type: Full-time