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 Quality Control Analyst (Microbiology) role will make an impact:

Position summary:

Responsible for the QC microbiology laboratory functions and the corresponding documentation to support the timely disposition of product.

Job Specific technical/Functional/Professional Competencies:

• Perform routine and non-routine microbiological testing of finished products, raw materials, utilities, and water systems in accordance with approved procedures.
• Perform environmental monitoring (viable and non-viable, where applicable) of classified manufacturing and laboratory areas and report any potential contamination sources to the Microbiology Supervisor.
• Perform growth promotion testing of culture media and maintain all associated records.
• Perform microbiological method suitability studies and verification activities as required.
• Perform disinfectant efficacy studies and support periodic requalification of disinfectants used within manufacturing and laboratory areas.
• Prepare, sterilize, qualify, and maintain microbiological culture media in accordance with approved procedures.
• Perform sampling and microbiological testing of purified water, and other utilities according to approved sampling plans.
• Perform internal calibration, equipment intermediate checks, and routine performance verification of laboratory instruments.
• Interpret, document, trend, and report microbiological results in the appropriate records and electronic systems.
• Ensure all test results are accurately recorded, reviewed, and reported in compliance with data integrity requirements.
• Investigate out-of-specification (OOS), out-of-trend (OOT), atypical results, and environmental excursions as assigned.
• Assist in the preparation, revision, and periodic review of SOPs, specifications, protocols, reports, and other controlled documents.
• Purify microbial isolates to single colonies using appropriate media and incubation conditions.
• Perform preliminary, confirmatory, and identification testing of microorganisms using approved methodologies.
• Maintain the departmental culture collection and ensure proper handling, storage, and traceability of microbial cultures.
• Complete and review associated logbooks, worksheets, records, and laboratory documentation in a timely manner.
• Participate in environmental monitoring trend analysis.
• Support laboratory investigations, deviations, CAPAs, change controls, qualifications, validations, and risk assessments related to microbiology activities.
• Ensure adequate inventory and availability of microbiological media, reagents, standards, consumables, and laboratory supplies.
• Participate in special projects and continuous improvement initiatives involving the Microbiology Department.

Experience and Knowledge

Ø Bachelor’s degree in pharmacy or scientific background.

Ø one (1) to five (5) years experience in a microbiology laboratory In GMP environment.

Ø Sound knowledge in general laboratory safety aspects.

Ø Good understanding of the pharmaceutical regulatory process.

Essential Personal Qualifications

· Bachelor’s degree in pharmacy or science.

· Good command of English language.

· Excellent interpersonal, communication and presentation skills.

· Demonstrated ability to work independently.

· Excellent documentation and technical writing skills.

· Good communications skills and ability to work in a team, interact with various priorities and meet deadlines.

· Active, organized and planner with high attention to details.

· High observation skills.

· Self-motivated and able to consistently meet timelines.

· Ability to use MS Office applications of MS Word, MS Excel, MS PowerPoint

At Viatris, we offercompetitivesalaries, benefitsandan 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.