Quality Assurance Analyst I – Review and Release

DPT Laboratories, Ltd.

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 QA Analyst I – Review and Release role will make an impact:

Key responsibilities for this role include:

• Act as QA Representative during client, vendor, or internal company interactions pertaining to topics related to team responsibilities. Answer questions and provide feedback to ensure Quality objectives are met.
• Maintain Quality metrics for both the department and clients.
• Place and maintain QA holds (product and controlled documents).
• Be familiar with the process to route and implement TrackWise records, managing appropriate action items as assigned.
• Identify and coordinate with Subject Matter Experts (SME) to gain the knowledge necessary to respond to requests outside of the scope of team responsibilities.
• Facilitate and adhere to efficiency improvements for the department.
• Review department Standard Operating Procedures (SOP) and Forms. Ensure compliance. Provide feedback for maintaining alignment with continuous improvement initiatives.
• Understand and comply with all applicable safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines, as well as applicable federal, state, and local regulations.
• Coordinate with team members to ensure all required tasks and timelines are met and completed.

For Product Release Team:

• Update Pending Release report for assigned client batches, daily minimum.
• Perform AQL set-up for batches issued.
• Perform final QA review and release of finished product batch records.
• Perform DEA tasks such as sample processing and batch reconciliation. (DEA qualified Analyst only)
• Create, revise, or approve standard specifications, as required. Add worksheets to formula codes.
• Perform Protocol review and be able to verify adherence to outlined requirements.
• Ensure analytical samples are delivered to appropriate locations and entered into the applicable system(s) correctly.
• Create and issue rework forms, as approved.

For Component Release Team:

• Update release trackers, daily minimum.
• Perform logbook verification or weigh room clearance, as needed.
• Perform final QA review and release of chemical and packaging components.
• Review receiving documentation packets.
• Create Notice of Rejection records (NORs).
• Manage physical movement of expired material* and perform electronic transactions.
• Perform DEA tasks such as material movement. (DEA qualified Analyst only)

The minimum qualifications for this role are:

• Minimum 0-2 years of industry related experience is required with a bachelor’s degree from an accredited four-year college or university; or equivalent combination of education and experience with minimum 5 years of Quality experience.
• Knowledge of GMPs and/or pharmaceutical-Quality or other regulated industry experience is preferred.

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.

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