Lead Specialist QA Operations (1st Shift) 12 Month Assignment

1100 Mylan Pharmaceuticals Inc.; St. Albans (VT); On-site; USD 66,000 - 127,000; Full time

Job summary

Viatris is seeking a Lead Specialist QA Operations (1st Shift) in Vermont to lead QA staff development and oversee batch record reviews and deviations. The role emphasizes cross-functional collaboration and strategic QA planning in a GMP environment.

The successful candidate will mentor QA Specialists, oversee event triage, investigations, and continuous improvements within the quality system, and ensure timely quality deliverables in manufacturing operations.

Qualifications

• Bachelor’s degree, 10+ years of relevant experience in a GMP environment, and comprehensive knowledge of Quality Systems and cGMP.
• Effective written and oral communication and interpersonal skills, and an ability to constructively work across functional areas to achieve results.
• Maintain working relationships with individuals within Viatris to assure timely achievement of assigned goals.

Responsibilities

• Directly participate in the Training and Development of QA Specialists/Senior Specialists/Supervisors in QA Operations functions and GMP regulations.
• Provide leadership and, as directed by management, daily oversight of the Quality Assurance Specialists
• Lead and participate in quality improvement team activities, and participate in cross-functional teams, providing QA input.
• Assist Management with strategic planning of intermediate batch record review/release, finished product batch record review, and other QA Specialist floor operations.
• Oversee QA Specialists’ evaluation and triage of events, deviations, and unplanned maintenance activities.

Skills

GMP knowledge

Quality Systems

cGMP knowledge

Leadership/Training

Cross-functional collaboration

Communication skills

Education

Bachelor's degree

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.This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.Every day, we rise to the challenge to make a difference and here’s how the Lead Specialist QA Operations (1st Shift) role will make an impact:Key responsibilities for this role include:Directly participate in the Training and Development of QA Specialists/Senior Specialists/Supervisors in QA Operations functions and GMP regulations.Provide leadership and, as directed by management, daily oversight of the Quality Assurance SpecialistsLead and participate in quality improvement team activities, and participate in cross-functional teams, providing QA input.Assist Management with strategic planning of intermediate batch record review/release, finished product batch record review, and other QA Specialist floor operations.Oversee QA Specialists’ evaluation and triage of events, deviations, and unplanned maintenance activities.Oversight of On-Hold material program, mentoring QA Specialists/Supervisors in monitoring and disposition of material.Perform QA review/approval of controlled documents, written procedures, protocols, and MES recipes, as required.Prepare and provide information for inclusion in monthly quality metric reports.Assure deviations are appropriately reported. Participate in investigations of deviations, as required.Support review and approval of Trackwise incidents related to manufacturing operations.Identify and implement continuous improvements for the elements of the quality system related to manufacturing operationsThe minimum qualifications for this role are:Bachelor’s degree, 10+ years of relevant experience in a GMP environment, and comprehensive knowledge of Quality Systems and cGMP. A combination of experience and/or education will be taken into consideration.Effective written and oral communication and interpersonal skills, and an ability to constructively work across functional areas to achieve results. Ability to multi-task a number of projects and evaluate priorities with minimal supervision. Maintain working relationships with individuals within Mylan Technologies and Mylan, Inc. to assure timely achievement of assigned goals.Exact compensation may vary based on skills, experience, and location. The salary range for this position is: $66,000 - $127,000.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.