Manager, QC Instrument Specialist - Devens, MA
Manager, QC Instrument Specialist - Devens, MA
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.
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 with the resources to pursue their goals both at work and in their personal lives.
Manager QC Instrument Specialist Bristol-Myers Squibb Company Devens MA. Lead qualification of quality control analytical instruments and other lifecycle activities. Design manage and implement applicable validation documents such as test scripts User Requirement Specification Design Qualification validation plans Data Integrity assessments risk assessments installation/operation qualification protocols and qualification summary reports. Champion qualification deviations/defects identifying root causes and Corrective Actions/Preventive Actions. Participate in an Instrument Lifecycle Community of Practice to include multiple commercial QC sites with a focus on sharing best practices identifying key risks reviewing regulatory and inspection trends and driving towards lifecycle/qualification standardization. Own change controls impacting QC equipment/software. Update asset management database to reflect new assets calibrations and preventative maintenances. Act as the liaison between Digital Plant (Information Technology) and lab departments. Perform instrument periodic assessments/decommissioning. Coordinate with external vendors for support. (R1592884)
40 hrs/week Mon-Fri 8:30 a.m. - 5:30 p.m.
Additional Qualifications/Responsibilities
MINIMUM REQUIREMENTS:
Bachelor of Science degree in Engineering Management or a related field plus 4 years of post-baccalaureate experience in analytical instrument hardware/software qualification/validation.
Experience must include the following:
Laboratory systems such as Empower NuGenesis and other software programs;
Current cGMP (Good Manufacturing Practices) regulatory requirements computerized analytical systems;
Quality management system including document control/management owning change controls investigations deviations electronic validation database execution and asset management database;
Organizational/team leadership;
Regulatory body audit;
Computer system validation; and
Coordinating with and influencing global level validation teams and processes.
The required skills do not need to be maintained over the full term of required experience.
May work remotely 1 day per week within normal commuting distance of Devens MA.
Required Experience:
Manager
Employment Type
Full Time
