QC Operations Senior 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.

Position: Senior Specialist, QC Microbiologist EM

Location: Devens, MA

Hiring Supervisor: Blendi Ceci

Roles and Responsibilities

Performs routine environmental monitoring (EM) and clean utilities (CU - Compressed Gasses) sampling and testing in accordance with SOPs, safety, and cGMP guidelines to support routine operations.

Monitor critical operating parameters for equipment and instrumentation to ensure standard operation.

Recognize, report, and document deviations from test methodologies, specifications, and alert limits.

SME in in multiple methodologies.

Provides support, training, and troubleshooting for day to day routine Environmental Monitoring and Clean Utility sampling.

Leads low-risk investigations.

Review of EM and CU data.

Communicates issues, technical failures, and activity status updates to direct supervisor. Provide direct support to junior personnel to troubleshoot Tier 1 issues.

Authors and Revises SOPs or sampling protocols for managerial review and approval. Trained on multiple methodologies, and provides support to a broader spectrum of testing responsibilities.

SME in multiple methodologies.

Drafting of quarterly/yearly trend reports for EM and CU data.

Participate on a variety of teams in support of business process and improvement projects. Represents QC EM Team at site, company and external system meetings.

Observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending corrective action.

May be assigned a team leader overseeing day to day execution of a shift of junior analysts.

Knowledge and Skills

Knowledge of science generally attained through studies resulting in a B.S., in biological sciences, a related discipline, or its equivalent. A minimum of 6 years experience in cGMP Biologics or related cGLP or cGMP lab. Proficiency (or mastery) of one or more of the methodologies within the QC sub-team. Excellent manual dexterity including proficiency in aseptic techniques. Strong detail orientation with good organizational skills. Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. Ability to interpret and apply cGMP, USP, regulatory requirements and industry best practices. Proficiency in applying cGMP regulations and compendial testing required. Demonstrates leadership, and independent problem solving and analytical thinking skills. Ability to execute problem solving with support of area lead or managements. Proficiency with basic electronic systems (email, MS Office, etc…) Experience with LIMS and ELN computer applications preferred.

Working Conditions

Work is performed in a cGMP compliant laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials. Overtime work may be required on weekdays, weekends, and holidays on short notice. Work may be required during adverse weather conditions. Flexibility to work irregular hours on short notice is support of manufacturing facility.

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.

Company: Bristol-Myers Squibb

Req Number: R1522471_EN

Updated: 2020-03-04 00:00:00.000 UTC

Location: Devens,Massachusetts

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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