QC Investigation Lead (Fitchburg)

Compensation

: $83,345.00 - $149,650.00 /year *

Employment Type

: Full-Time

Industry

: Law Enforcement



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.

Summary:

Conducts and manages Quality investigations and documents investigations and CAPAs per approved SOPs. Leads investigation teams, facilitates meetings and proactively manages progression and communicates to functional area management. Monitors and reports progression of all QC Investigations and CAPAs. Proactively identifies and facilitates resolution of obstacles to timely completion. Evaluates data for system performance and development of presentations

Responsibilities:
  • Conducts and manages Quality investigations into deviations and documents investigations and CAPAs per approved SOPs.
  • Leads investigation teams, facilitates meetings and proactively manages progression and communicates to functional area management.
  • Monitors and reports progression of all QC Investigations and CAPAs. Proactively identifies and facilitates resolution of obstacles to timely completion. Evaluates data for system performance and development of presentations
  • Drafts and reviews change controls and SOPs, Work instructions and Material Specifications.
  • Monitors Quality control data to proactively identify areas for program enhancement. Collaborates with functional area personnel and Quality system owners to facilitate implementation of process improvements.
  • Uses Quality Risk Management and Operations Excellence principles to lead projects and resolve issues.
  • Participates in audit response development and management of response timeline and CAPA identification.
  • Assists in review of draft revisions to WWQCs. Conducts gap assessments and develop and monitor completion of Devens site remediation plans.
  • Work within office environment.
  • Works independently and if identifies issues or problems, work with Management to resolve.
  • Receives majority of assignments which require the application of a defined process to complete the assignment with some variability in application depending on potential impact / scope of the assignment. As such specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly.
    Some assignments will require recipient to define specific details within their own judgement with counseling from supervision as needed.


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 4 years of relevant experience in a regulated environment
  • Knowledge of US and EU cGMP regulations and ICH guidance.
  • Knowledge of Aegis (Discoverant), SAP, LIMS and Trackwise desirable.


Position is Monday to Friday 1st shift.

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: crime scene, detective, fingerprint, inspector, investigate, investigation, investigative, investigator * 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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