QA Specialist, Operations - 3rd shift

Lonza • Tampa, FL

2d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• Experience in audits and regulatory compliance processes is advantageous

Responsibilities

• 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

Benefits

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level