QA Compliance Specialist II

United States, Tampa (Florida)

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, Florida is looking for an experienced Quality Assurance Compliance Specialist II who assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing.  Alternatively, conducts internal production/process and manufacturing quality control audits and risk assessments.  Role may be in Compliance, Lot Review or Audit/Inspection.

Key Responsibilities:

  • Oversight for compliance of change controls, CAPA (Corrective and Preventative Action), investigations, deviations and OOS (Out of Specification)
  • Performs document reviews of SOP’s (Standard Operating Procedures), batch records, test methods, and logbooks to ensure cGMP (Good Manufacturing Practices) activities are completed and documented in accordance with approved, written procedures. May also review raw materials, work orders, validation and MSAT (Manufacturing Sciences and Technology) reports
  • Independently writes SOPs or associated documentation
  • Independently approves SOPs, Master Batch Records, customer audit and regulatory CAPA
  • Assesses potential impact to product quality for open deviations during lot release
  • May participate in investigations into minor major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity
  • Runs the back room during audits and inspections
  • Leads internal and external audits, and tracks audit and inspection commitments
  • May be responsible for hosting or leading a team in the front room for customer audits and regulatory inspections
  • Makes recommendations of changes to processes and programs
  • Trains new team members.

Key Requirements:

  • Bachelor Degree in Science or Engineering related field
  • Substantial Quality Compliance experience within the pharmaceutical/biotech industry is required. Preferred experience working in commercial drug product environment
  • Demonstrated supplier management and audit experience
  • Excellent communication skills (written and oral) with ability to influence people and outcomes
  • Ability to work in a deadline driven environment
  • Candidates must be self starter

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. 

Reference: R34085