Quality Assurance - Lot Review Specialist

United States, Rochester (New York)

Quality Assurance - Lot Review Specialist

What makes YOU different?

Lonza Specialty Ingredients (LSI) combines technological innovation with world class manufacturing and process excellence. Microbial Control Solutions serves consumer and technical markets by safeguarding resources and peoples’ wellbeing. We are a trusted and innovative supplier of microbial control solutions and chemical technologies used in a wide range of industrial and consumer solutions. Our vast product portfolio of microbial control and chemical technologies offer quality products backed by technical and regulatory expertise, meeting our customers’ current and future needs.

LSI is looking for a Quality Assurance Specialist for our Rochester, NY office. This role supports Quality Assurance efforts with an emphasis on ensuring required procedures are followed.  Must have a working knowledge of Quality systems including deviations, CAPA, document change and process change procedures. Other key duties include: full review of completed batch records to ensure compliance with cGMP, compiling batch documentation for lot release in a timely manner, and ensuring all associated events are investigated and closed prior to lot release.

Key Responsibilities:

  • Review completed batch records to ensure compliance with cGMP.

  • Compile batch documentation for product release while ensuring all deviations and OOS investigations are closed prior to release.

  • Assist with OOS investigations, CAPA, Deviations, and MOC’s as needed.

  • Generate Certificates of Analysis, fix errors with Certificates of Analysis.

  • Edit/Review SOP’s and protocols.

  • Provide back room support during regulatory audits.

  • Participate in Internal AuditsGeneral understanding of regulatory and standards and the quality systems to uphold them.

  • Responsible for wearing all required PPE at all times and maintaining a safe working environment.

  • Perform other duties as assigned.

Key Requirements:

  • BS/BA in a Science related field

  • 1-4 years experience or work study experience

  • Knowledge of cGMPs, EFfCI and ISO standards is required

  • Must be able to perform the physical aspect of the job including bending, squatting and lifting

A major part of the heritage of LSI is being able to deliver unique solutions to its customers. Being the driving force behind this approach – listening, asking, understanding to match the right elements in a new way has been an inherent part of our day-to-day business. Always with the goal to enable a competitive advantage for each customer with a specific product, package or solution.

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: R27623