QA Specialist, Operations - 12hr Day or Night Shift
Lonza
Summary
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.
Job description
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.
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
- Experience in audits and regulatory compliance processes is advantageous
Benefits
- Performance-related bonus
- Medical, Dental & Vision
- 401(k) Matching
- Life Insurance
- Short & Long-Term Disability
- Employee Assistance Programs
- Paid Time Off
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.