Bristol Myers Squibb Group Leader - Documentation and Training in New Brunswick, New Jersey
The Group Leader – Documentation and Training is responsible for creation, utilization and archiving of documentation and training processes in support of GMP operations. The individual will strive for ‘right the first time’ quality of operations and maintain a high level of awareness/compliance in an evolving Regulatory environment. This position may participate in matrix based teams and/or act as department representative on assigned teams. As a proponent for change, the individual will explore areas for gains in efficiency and quality while appropriately balancing speed and risk.
Oversees manufacturing master batch record (MBR) writing, review and approval
Responsible for DeltaV Phase (i.e. MBR and Equipment Cleaning Logbook Recipes (ECLRs) designs, modifications, implementations – works in conjunction with the Automation group, Operating Personnel and Document Coordinator/Specialist
Writes/revises SOPs and Work Instructions
Ensures that all manufacturing related GMP documents, such as equipment qualification protocols, equipment and facility change control records, cleaning records, SOPs, etc. are properly stored and archived, when needed
Establish and oversee training programs in Clinical Supply Operations groups (DP manufacturing, Packaging and Labeling and Integrated Supply Chain) including ‘train the trainer’ programs and to assure training process alignment across the departments.
Conducts departmental investigations as a follow-up to Quality Events; proposes Corrective and Preventive Actions
Responsible for creation and maintenance of training items and curriculum
Communicates effectively with management, quality unit, peers and colleagues within and outside the department for all documentation related issues.
Establishes effective plans for self and direct reports to manage assigned workload and projects
Participates in and enables high performing teams by removing communication barriers and energizing the team to achieve shared goals
Produces accurate and high quality deliverables for assigned projects
Makes and acts on functional area task decisions while balancing speed, quality, and risk
Identifies and escalates technical and/or business issues promptly; ability to solve routine issues independently.
Understanding of cGMP’s as they relate to evolving domestic and international Regulatory standards coupled with an awareness of new industry trends
Establishes and maintains a safe work environment for self and co-workers
Mentor/coach/train Documentation Specialists.
Minimum of a Bachelor's Degree in the Sciences (Biology, Microbiology, Chemistry, Pharmacy).
Must have 8 to 12 years of experience in a Pharmaceutical or Biotech Manufacturing organization
Minimum four years editing or creating documents in a regulated industry
Working in busy operations with tight deadlines and high workloads
Knowledge of review processes and quality functions
Experience in providing training and train the trainer programs.
Strong understanding of GMP environments
Technical writing experience preferred
Excellent understanding of document control processes
Excellent comprehension of documentation systems and flows
Strong knowledge of cGMP environment/industry as well as scientific language
Advanced level in MS Suite applications, particularly Word and Excel
Experience with document management systems (DMS)/document control practices
Coherent and effective interpretation of written and verbal instructions
Self-starter; problem-solver; highly organized; flexible
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.