Senior Specialist, QA Operations

Regulatory Toolkit; St. Albans (VT); On-site; USD 55,000 - 105,000; Full time

Job summary

Viatris is hiring a Senior Specialist, QA Operations to review batch records, release materials and ensure GMP compliance. The role involves leading deviation investigations, driving continuous improvement, and training staff in QA systems.

Requires a Bachelor’s degree and 4 years in a GMP environment with knowledge of cGMP/ICH standards. The position is based in the United States (Vermont) with on-site responsibilities and opportunities to contribute to quality systems and training programs

Qualifications

• Bachelor’s degree with 4 years of relevant GMP experience or equivalent combination of education/experience.
• General knowledge of Quality systems for Pharmaceutical Industry (cGMP, ICH, Pharmacopoeia) and Medical Products (ISO, IPEC).
• Computer proficiency with MS Word, Excel, Access and Project.

Responsibilities

• Review in-process batch records, finished product batch records, and intermediate analytical records.
• Release intermediate materials.
• Assess manufacturing operations and process documentation for GMP compliance.
• Lead evaluation and triage of events, deviations, and unplanned activities.
• Ensure deviations are reported; participate in investigations as required.
• Identify improvement opportunities and lead QA projects for continuous quality system improvement.
• Serve as QA Subject Matter Expert in elements of the manufacturing process.
• Maintain QA retain inventory and perform annual retain inspections.
• Conduct QA training and develop SOPs, QFs and training modules.

Education

Bachelor’s degree in a GMP/QA related field

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 upon 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.