Bristol Myers Squibb Senior Quality Assurance Operations Specialist in Devens, Massachusetts
The Sr Quality Specialist - QA Operations is responsible for managing Quality Assurance aspects related to Quality laboratory operations. This includes quality oversight on laboratory-based initiatives such as technical transfers, equipment and method changes, investigations, and periodic trending and reporting. This role will liaise with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution, and act as a QA representative on associated projects related to Quality laboratory operations.
Responsibilities:• Provides quality support through quality review and approval of investigations or change controls.• Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of laboratory operations including, incoming, in-process, release, and stability testing.• Reviews and approves laboratory periodic trending and performance reports• Reviews and approves LIMS and LES changes
• Liaises with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution• Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.
• Ensures clear communication on issues and timely escalation as applicable• Helps maintain site practices and procedures related to laboratory instrument qualification, usage, and method execution and trending, ensuring compliance with regulatory expectations
• Drives opportunities for continuous improvement.
• Lead and manage governance owned by QA Lab Ops
• Conduct quarterly walkthroughs of QC Laboratories
• Mentor/Coach more junior QA Lab Ops roles and new lead investigators
• Provide direct audit support, and participate in response team for audits and inspections by Health Authorities
• Point of contact for QA Lab Ops in managers absence
Qualifications:• 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 quality operations desired• Knowledge of biotech bulk and finished product manufacturing and associated analytical testing is highly desirable. • Knowledge of US and EU cGMP regulations and guidance.• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, SmartLAB and Syncade desirable.• Demonstrated experience working in a team based environment across functional areas, with diverse group of people.• Demonstrated proficiency in common computer tools such as Microsoft Office suite, and web based applications.
• Excellent writing and oral communication skills are required• Previous work experience where attention to detail and personal accountability were critical to success.• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, and apply knowledge of subject matter expertise.
• Knowledge of Biotech bulk finished product analytical/microbiological testing is highly desired.
• Contacts primarily with QA and QC Operations, and may also include MST and contacts outside the Devens site.
Exercises judgment within general defined practices and policies in selecting methods and techniques for obtaining solutions.
Makes sound decisions and applies appropriate notification to management as appropriate.
Receives little supervision and identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective action.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
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.