What are the responsibilities and job description for the Specialist, QA Operations, 1st Shift position at Viatris?
Mylan Technologies, Inc.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
- Access – Providing high quality trusted medicines regardless of geography or circumstance;
- Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the 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.
Participates in the evaluation and triage of events, deviations, and unplanned activities that impact processes and/or materials.
Assure deviations are appropriately reported.
Identifies improvement opportunities and participates on project teams geared toward continuous improvements for the various elements of the quality system.
Perform annual retain inspections.
Assists with the revision of SOP's, QF's and training modules as needed.
Attends training classes and seminars as needed.
The minimum qualifications for this role are:
- Minimum of a Bachelor's degree (or equivalent) and 0-2 years of experience in a GMP environment, however, a combination of experience and/or education will be taken into consideration.
- Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
- Must possess excellent communication skills, time management skills, organizational skills, interpersonal skills, writing skills and possess exceptional attention to detail and the ability to apply critical thinking skills. Basic computer skills (Microsoft Word, Excel, PowerPoint and Outlook) also required. Additional computer skills in Trackwise, Documentum, LIMS, SAP and Minitab also highly desired.
- 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 $41,000 - $93,000.
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.
Salary : $41,000 - $93,000