Senior Specialist, QA Operations – 1st Shift

Viatris•St. Albans, VT

1d•$55,000 - $105,000

About The Position

The Senior Specialist, QA Operations supports quality assurance activities for manufacturing operations. The role reviews batch and analytical records, releases intermediate materials, assesses operations and documentation for GMP and SOP compliance, and leads the evaluation and triage of events and deviations. It also contributes to investigations, continuous improvement projects, quality-system training and documentation, and QA subject-matter expertise for specific manufacturing processes.

Requirements

Bachelor’s degree and 4 years of relevant experience in a GMP environment; a combination of experience and/or education will also be considered.
Fundamental understanding of Quality Systems and cGMP.
General knowledge of pharmaceutical-industry quality systems, including cGMP, ICH, and Pharmacopoeia requirements, and medical-products requirements, including ISO and IPEC.
Knowledge of and familiarity with computers and software such as MS Word, MS Excel, MS Access, and MS Project.

Responsibilities

Review in-process batch records, finished product batch records (Pharmaceutical and/or MPD), and intermediate analytical records.
Release intermediate materials.
Assess manufacturing operations and process documentation for compliance with GMPs and Standard Operating Procedures.
Lead the evaluation and triage of events, deviations, and unplanned activities that affect processes or materials.
Ensure deviations are appropriately reported and participate in investigations as required.
Identify improvement opportunities and lead departmental project teams focused on continuous improvement of the quality system.
Serve as a QA Subject Matter Expert for 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.
Develop and maintain SOPs, QFs, and training modules as needed.
Attend training classes and seminars as needed.