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Job Details


Bristol-Meyers Squibb, Co.

Documentation Manager, Clinical Supply Operations

Pharmaceuticals

All

Full Time

On Site

No

New Brunswick, New Jersey, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Creates and maintains GMP documentation such as but not limited to Master Batch Records (DeltaV and SAP), cleaning recipes, Standard Operating Procedures (PDHQ) and Training (ELMS e.g. SuccessFactors) for CSO Parenteral and Oral Solid Dosage Manufacturing.

Responsibilities:

  • Writes/revises manufacturing master batch records (MBR) and obtains formulation scientists and QA approvals on the written MBRs.
  • Conducts simulation of DeltaV MBRs with operating personnel for ease of execution.
  • Supports batch record execution.
  • Participates in the introduction of new product as part of technology transfer. This encompasses facility/equipment/systems readiness, safety preparedness and test methodology activities.
  • Communicates effectively with management, quality unit, peers and colleagues within and outside the department for all documentation related issues.
  • Participates in selected initiatives leading to the improvements on cGMP compliance, safety compliance and productivity.
  • Supports implementation and maintenance of the Electronic Cleaning Logbook Recipes (ECLRs)

Qualifications:

  • A minimum of 3-5 yeasr of relevant experience focused on documentation and training is desired.
  • Knowledge of cGMP regulations is preferred.
  • Strong knowledge of and experience with Microsoft Word & Excel, Records Management Systems, and ELMS/EDMS software –such as SuccessFactors & Syncade – is desired.
  • Requires excellent communication skills and the ability to work in a team based environment and interact well with other employees at various levels.
  • Individual must demonstrate strong organizational skills, flexibility, and have the capability to handle several high priority items simultaneously on an ongoing basis
  • Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
  • Must possess trouble shooting skills

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.