Quality Assurance Operations Specialist

Profile

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:

The 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

• Liaises with internal partners (e.g. Quality control, analytical technology functions) in support of daily operations and conflict resolution

• Acts as a QA representative on associated projects related to Quality laboratory operations. 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 and drives opportunities for continuous improvement.

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 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality 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.

• Past experience where one was required to work in a team based environment with a diverse group of people.

• Excellent writing and oral communication skills are required

• Demonstrated attention to detail, and the ability to perform well in a team-based environment are required.

• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, and apply knowledge of subject matter expertise

• Excellent computer skills and proficiency with MS Office is required.

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.

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com