Specialist, QA Operations, 2nd Shift

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<div class="isg-job-description“>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), andintermediateanalytical records.

• Release intermediatematerials.

• Assess the manufacturing operations and process documentation for compliance to GMP’s and Standard Operating Procedures.

• Participates in the evaluationand triage of events, deviations, and unplanned activities thatimpactprocesses and/or materials.

• Assuredeviationsareappropriatelyreported.

• Identifiesimprovementopportunities andparticipateson projectteams gearedtoward continuous improvements for thevariouselementsofthequalitysystem.

• Perform annualretaininspections.

• 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.

• Abilitytoreadandinterpretcomplexbusinessand/ortechnicaldocuments.Abilitytowritecomprehensivereportsanddetailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.

• Mustpossessexcellentcommunicationskills,time management skills,organizational skills,interpersonalskills,writingskillsandpossessexceptionalattentiontodetailandtheabilitytoapplycriticalthinkingskills.Basiccomputerskills(MicrosoftWord,Excel,PowerPointandOutlook)alsorequired.AdditionalcomputerskillsinTrackwise,Documentum,LIMS,SAPandMinitabalsohighlydesired.

• Mustpossessgeneralknowledge of Quality systems for the PharmaceuticalIndustry (cGMP,ICHand Pharmacopoeia requirements) and Medical Products (ISO, IPEC). Mustpossessknowledgeandfamiliaritywithcomputersandvarious software such as MS Word, MS Excel, MSAccessand MS Project.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $41,000.00 – $93,000.00 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.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â

 

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