Bristol Myers Squibb Investigation Lead, QC Technical Support in Devens, Massachusetts
Bristol-Myers Squibb is seeking top talent for our Quality organization. The purpose of this evergreen req is to gather qualified candidates for an expected need in the near future. If you're interested in being contacted when this job becomes available, please apply and a recruiter will contact you when it does.
Reporting to the QCTS Manager, QC Services this role will be primarily responsible for leading quality event investigations following standard root cause analysis methodology. Incumbent may be assigned other duties, and may participate on a variety of network teams (technical/ strategic) in support of business processes/improvements.
KNOWLEDGE AND 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; experience in analytical or QC testing of pharmaceuticals or biologics is desirable.
Strong analytical, interpersonal, communication, organization, and project management skills; ability to work on a team and independently.
Demonstrated ability to collect, analyze, and integrate information, present ideas, issues, and observations into a clear and useful format, and balance several projects in a fast-paced team environment
Familiarity of US and EU cGMP regulations and ICH guidance.
Knowledge of Aegis (Discoverant), SAP, LIMS and Trackwise is desirable.
MAJOR DUTIES AND RESONSIBILITIES:
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 by participation in group, department, and process meetings.
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
Review Standard Operating Procedures, and identify potential areas of improvement/conflict, and interface with laboratory management, quality department, and manufacturing operations.
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.
This role has business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Automation, Technical Services, EHS and Manufacturing staff. Less frequent contact with general business functions including human resources, and Finance and BMS staff at other locations, including corporate headquarters. Occasional contact with outside vendors and contact with representatives from health authorities / regulatory agencies during site audits.
Work is largely performed in a modern office and a cGMP laboratory / manufacturing facility where one must maintain a high attention to detail and to be aware of the presence of workplace hazards including pressurized liquids gases, steam, biohazards and hazardous chemicals. The use of Personal Protective Equipment (PPE) will be required in the laboratories and in some portions of the facility.
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.
SUPERVISION EXERCISED: Oversees and provides guidance to non-exempt staff as required.
Travel Required: Up to 5%
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.