• Bristol-Myers Squibb Company
  • $94,360.00 -141,170.00/year*
  • Franklin , MA
  • Manufacturing
  • Full-Time
  • 254 Beaver Street


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Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PRINCIPAL OBJECTIVE OF THE POSITION: Coordinate the receipt of deliverables to support disposition of incoming materials, or products manufactured at the Devens site, from cross-functional responsible parties. Perform review of disposition deliverables in preparation of Quality Management review and disposition of batches within inventory management systems. Assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. Provide redundancy support of release of raw material and consumable materials as well as review of manufacturing batch records to support disposition initiatives.

Responsibilities:
  • Executes operating procedures for the site quality assurance program, which supports the disposition of manufactured products. This includes the coordination of receipt of deliverables required for material disposition from cross-functional responsible parties. Prepares disposition documents in accordance with SOPs for Quality Management approval. Responsibilities also include updates to lot status in applicable quality systems.
  • Provides guidance to less experienced staff with atypical events during day-to-day operations.
  • Provides back-up support for the inspection and release of consumable and raw materials in accordance with written SOPs and specifications.
  • Other responsibilities include:
    • Authoring and review of SOPs.
    • Leading DS disposition visual mgmt. process
    • Management of SAP and Syncade Master Data.
    • Review of change controls to determine the need for market controls, and implementation of market controls when applicable.
    • QA Operations SME for SAP
    • SME for disposition process for regulatory inspections
    • Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained. Includes the documentation, follow up and escalation of observations and areas of concern.

      Key Core behavioral indicators for this role include: Participates in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals. Demonstrates appropriate examples of compliance behaviors and attitudes.
  • May also perform manufacturing batch record review, master batch record approval and other activities in support of the quality assurance operations team.


Knowledge/Skill:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
  • A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
  • A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality.
  • Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition, deviation investigations and batch record review is highly desirable.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, and electronic batch recording systems, is desirable. Microsoft Office Suite knowledge and proficiency with Excel is desirable.
  • Knowledge in Operational Excellence and Continuous Improvement is desirable.
  • Excellent writing and oral communication skills are required.
  • Previous work responsibility, which required a high degree of attention to detail.
  • Well practiced in exercising sound judgment in decision-making.
  • Demonstrated multitasking and organization skills.
  • Past experience where one was required to work in a team based environment with a diverse group of people.


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.
Associated topics: calibrate, criteria, defect, qa, qa tech, quality, quality control/quality assurance, quality manager, quality technician, requalification

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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