Senior Quality Control Analyst

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.
 

Every day, we rise to the challenge to make a difference and here’s how the “Sr. Quality Control Analyst” role will make an impact:

Key responsibilities for this role include:

• Conduct routine and non-routine analyses of in-process materials, finished goods, and stability samples in a timely manner.
• Interpret test results, compare them with established specifications and control limits, and make recommendations regarding the suitability of data for release.
• Conduct chemical and physical laboratory tests to perform qualitative and quantitative analyses.
• Complete documentation required to support testing activities, including data capture forms, equipment logbooks, and inventory records.
• Ensure compliance with Data Integrity principles and Good Documentation Practices (GDP) in all laboratory activities.
• Prepare technical reports, graphs, and charts to document and communicate experimental results.
• Participate in out-of-specification (OOS), out-of-trend (OOT), and laboratory failure investigations, and recommend appropriate corrective and preventive actions (CAPAs).
• Provide quality control data required for regulatory submissions.
• Investigate and report questionable or atypical test results.
• Perform data entry, statistical analysis, and trend analysis activities.
• Execute activities related to process validation, cleaning validation, and instrument qualification.
• Prepare and execute SOPs, calibration protocols, validation protocols, and qualification documents (IQ, OQ, and PQ) related to chemical laboratory activities.
• Ensure implementation of Viatris Policies and requirements applicable to chemical laboratory operations.
• Manage, monitor, and control reference standards inventory and expiry status.
• Manage, monitor, and control inventory and expiry status of laboratory stock items, including reagents, glassware, filters, and other laboratory consumables.
• Author, review, and revise Quality Control SOPs.
• Drive continuous improvement initiatives through the implementation of Lean and Six Sigma projects.
• Ensure QC compliance through the timely closure of Viatris Policies actions, internal audit observations, EDA actions, and data integrity actions.
• Act as delegate for the QC Finished Goods Section Head, including batch disposition/release activities and other assigned managerial responsibilities during periods of absence.

Experience and Knowledge

• Working knowledge of current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP), with particular emphasis on Quality Control operations.
• Knowledge of analytical laboratory techniques and laboratory instrumentation, including pH meters, UV-Visible spectrophotometers, High-Performance Liquid Chromatography (HPLC), and reagent preparation.
• Familiarity with laboratory investigations, data integrity requirements, and Good Documentation Practices (GDP) is preferred.
• Experience with laboratory computerized systems and electronic data management is an advantage.
• Knowledge of pharmaceutical testing requirements, specifications, and regulatory expectations is preferred.

Minimum Qualifications for this Role

• Bachelor's degree in Pharmacy, Chemistry or Pharmaceutical Sciences.
• 2–4 years of experience in a pharmaceutical Quality Control laboratory.
• Good command of the English language, both written and spoken.
• Strong technical writing, documentation, and communication skills.
• Proficiency in Microsoft Office applications (Word, Excel, and PowerPoint).
• Strong organizational, analytical, and problem-solving skills, with the ability to work independently and effectively within a team environment.
• Ability to manage multiple priorities, work under pressure, and meet deadlines.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.