Lead Specialist, Quality Systems – 1st Shift

Mylan Technologies•St. Albans, VT

1d•Onsite

About The Position

Mylan Technologies, Inc. Viatris is a global healthcare company dedicated to bridging the divide between generics and brands to holistically address healthcare needs worldwide. Their mission is to empower people globally to live healthier at every stage of life, providing access to high-quality medicines to approximately 1 billion patients annually. The company has been recognized on various award lists for its impact. This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities. The Lead Specialist, Quality Systems role is crucial in making a difference every day.

Requirements

BS degree and 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.
Must possess a working knowledge of cGMP and Quality Systems.
Must understand the cGMP standards for the change control and change implementation with basic understanding of regulatory expectations in relation to change management.
Ability to add, subtract, multiply and divide.
Statistical Analysis, Advanced Mathematical calculations.
Must possess strong communication skills (written and verbal).
Must have experience in technical writing.

Responsibilities

Lead complex / critical investigations, trends, propose associated CAPA actions and prepare associated investigation reports.
Represent QA in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact.
Leads / facilitates cross functional structured problem solving in support of investigations.
Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides.
Present to local and vertical leadership as required.
Performs PQRs
Provides oversight/assessment for Potentially Critical Complaints
Leads periodic and special cause trending assessments to determine corrective actions to address trends.
Compiles/Analyzes investigation system related reports to support APRs/PQRs, Management Review, and Site Metrics.
Provides leadership and oversight for assigned elements of the Site Quality System
Leads continuous improvement project teams.
Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion.
Approves laboratory investigations, incidents, and investigations as authorized.
Serves as Site Contact/Back up for Global Initiatives related to improvement of Quality Systems
Provides mentorship and supports training/development of Quality Systems Specialist/Senior Specialist
Supports external Audits (ie Corporate, Vendor, ISO etc) and Health Authority Inspections