QA Specialist II, Compliance at US31 Lonza Tampa LLC in Tampa, Florida

Job Description:

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Tampa is seeking an experienced professional who assists and supports the organization with initial compliance and ongoing preparation, and monitoring of conformance to established quality assurance processes and standards. A qualified candidate conducts internal production/process and manufacturing quality control audits and risk assessments. Role reports to QA Compliance.

Key Accountabilities:

• Performs document reviews of SOP’s, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures.  May also review raw materials, work orders, validation and MSAT reports.  




• Independently writes SOPs or associated documentation.




• Independently approves SOPs, customer audit and regulatory CAPA.




• Works with technical transfer teams to prepare new processes; act as responsible QA designee 




• Approves Laboratory Data and Reports.




• Assesses potential impact to product quality for open deviations during lot release. 




• Review for compliance of change controls, CAPA, investigations, deviations and OOS.




• Lead complaint management process




• Participates in investigations into root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity. 




• Problem solving ability to resolve basic to moderate quality issues




• Leads internal and external audits, and tracks audit and inspection commitments.




• Independently hosts customer audits or leads a team during regulatory inspections 




• Creates and presents training seminars on cGMP issues




• Owns and leads special projects, often complex in nature    




• Makes recommendations of changes to processes and programs. 




• Trains new team members.




• Performs additional job-related assignments as requested by management




• Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear




• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible




• Stop work where deemed necessary to maintain safety




• Basic computer skills and preference for experience with Trackwise, SAP, Documentum

Key Requirements:

• Bachelors degree in Science




• Minimum of 5 years' experience




• Significant experience in cGMP pharmaceutical setting preferably oral solid dosage

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.