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Senior Quality Specialist

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts.
The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site.
Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
The Devens site currently has an opening for a Senior Quality Specialist.
Responsibilities include but are not limited to:
Manages Devens change control system as site gatekeeper and site system expert user (facilitates movement of records through the process, manages reviewer assignments, ensures compliance to established procedures).
Support the internal audit program as team member and/or lead auditor.
Develop, plan and conduct audits, write audit reports, review and track corrective actions and audit closures.
Provide support to the site Quality Management to ensure site compliance with applicable regulatory, cGMP and BMS requirements.
Acts as a facilitator for applicable internal audits and/or change control management committees and as a representative on associated business processes (may include coordinating meetings and minutes, tracking changes and ensuring resolution on decisions required to proceed).
Supports BMS network initiatives as the Devens site representative and coordinates intra- and inter-site reviews with fellow BMS gatekeepers and stakeholders.
Representative on TrackWise upgrade projects, as needed Maintains site procedures related to the audit and change control programs and drives opportunities for continuous improvement in support of enhanced quality system performance.
Manage program metrics process by developing applicable tools and trackers, generating and analyzing quality system data for trending, performance deficiencies, and conformance to KPIs.
Presents related metrics to site Quality and operations management.
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Generate TrackWise queries and reports as needed for audits and change control programs and during inspections.
Provides change control data related to support annual product quality reviews Support the Site Inspection Readiness Program by conducting prep sessions, internal audits, and mock inspections.
Participates as a core inspection team member during regulatory agency inspections and corporate audits.
Conducts user training on internal audits, inspection readiness and change control program, as needed Qualifications Knowledge of science or engineering generally attained through the studies resulting in a Bachelor's degree in a scientific or technical discipline.
A minimum of 6 years of relevant experience in a biologics or pharmaceutical manufacturing environment is required, 8 years is preferred.
Prior GMP compliance / Quality Systems experience is preferred Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the 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, including knowledge of applicable U.
S.
and E.
U.
cGMP regulations/guidance's pertaining to change control required Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, with demonstrated knowledge of subject matter related to quality and compliance Previous work experience with TrackWise and responsibilities related to metrics and data analysis preferred Candidate must be familiar with and able to interpret relevant regulations, regulatory agency inspection expectations e.
g.
FDA, EMA, Health Canada, etc.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1500975

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