Bristol Myers Squibb Quality Specialist in Devens, Massachusetts
To ensure audit readiness at the Devens site. This includes execution of self-inspection, change control and other site internal compliance with BMS corporate policies and directives (P&D) as well as management of Health Authority requests.
Acts as support auditor function for the self-inspection (i.e. internal audit) program at the site. Perform quality review of subsequent commitments to remediate identified gaps.
Acts as site gatekeeper to facilitate the site change control program - including coordination of risk-based impact assessments for specific change requests. Responsible for adherence to key performance indicators for high quality changes and on-time delivery.
Provides Quality Systems and Compliance data related to support Annual Product Quality Review (APQR) for manufacturing and testing activities at the site.
Reviews and assesses site compliance with BMS corporate policies and directive revisions, BMS network regulatory observations. Documents impact assessments and perform quality review of subsequent commitments to completion. Escalates site compliance issues accordingly.
Participates as a support team member in any corporate or regulatory agency inspections and lead cross functional teams to develop responses, tracking the commitments to completion.
Authors revisions to Site Master File.
Delivers training for site inspection readiness, change control, and self-inspection activities with functional areas.
A minimum of 3 or more years of relevant experience in a biologics or pharmaceutical manufacturing environment.
Knowledge of science or engineering generally attained through the studies resulting in a Bachelor’s degree in a scientific or technical discipline.
Basic project management skills (organization, collaboration, multi-tasking and communication),
High degree of attention to detail is a must
Ability to perform well in a team-based environment are required
Excellent computer skills and proficiency with MS Office is required. Advanced knowledge of Excel preferred.
Basic understanding of manufacturing processes, drawings and specifications and quality systems,
Knowledge of applicable U.S. and E.U. cGMP regulations/guidance is preferred.
Previous work experience with TrackWise and responsibilities related to metrics and data analysis is preferred.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.