Senior Specialist, QA Operations – 1st Shift

Viatris Inc.; Vermont; On-site; USD 55,000 - 105,000; Full time

Job summary

Viatris Inc. is a global healthcare company dedicated to bridging generics and brands to improve worldwide access to medicines. The Senior Specialist, QA Operations will review batch records, release materials and ensure GMP compliance across manufacturing processes.

The role also involves leading investigations of deviations, driving quality system improvements, and developing SOPs and training modules to support continuous QA operations.

Qualifications

• Bachelor’s degree; 4+ years of experience in a GMP environment.
• Solid understanding of quality systems (cGMP, ICH, ISO) and Pharmacopoeia basics.
• Proficient with standard software packages (MS Word, MS Excel, MS Access, MS Project).

Responsibilities

• Review in-process batch records, finished product batch records (Pharm. and/or MPD), and intermediate analytical records.
• Release intermediate materials and assess manufacturing documentation for GMP compliance.
• Lead evaluations of deviations and events; participate in investigations as required; drive continuous improvement of the quality system.
• Develop and maintain SOPs, QFs and training modules; conduct QA training activities.

Skills

Quality Systems

GMP knowledge

Computer literacy

Education

Bachelor’s degree

Tools

MS Word

MS Excel

MS Access

MS Project

Job description

Mylan Technologies, Inc.

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 Senior Specialist, QA Operations role will make an impact:

Key responsibilities for this role include:

• Review in-process batch records, finished product batch records (Pharm. and/or MPD), and intermediate analytical records.
• Release intermediate materials.
• Assess the manufacturing operations and process documentation for compliance to GMP’s and Standard Operating Procedures.
• Leads the evaluation and triage of events, deviations, and unplanned activities that impact processes and/or materials.
• Assure deviations are appropriately reported. Participate in investigations of deviations, as required.
• Identifies improvement opportunities and leads departmental project teams geared toward continuous improvement of the quality system.
• Fulfill role as QA Subject Matter Expert in specific elements of the manufacturing process.
• Maintain QA retain inventory and perform annual retain inspections.
• Conduct training activities related to QA operations and quality systems.
• Develops and maintains SOP’s, QF’s and training modules as needed.
• Attends training classes and seminars as needed.

The minimum qualifications for this role are:

• Bachelor’s degree, 4 years of relevant experience in a GMP environment, and a fundamental understanding of Quality Systems and cGMP. However, a combination of experience and/or education will be taken into consideration.
• Must possess general knowledge of Quality systems for the Pharmaceutical Industry (cGMP, ICH and Pharmacopoeia requirements) and Medical Products (ISO, IPEC).
• Must possess knowledge and familiarity with computers and various software such as MS Word, MS Excel, MS Access and MS Project.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $55,000.00 - $105,000.00 USD.

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.

All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.