Bristol Myers Squibb Hiring for Sr Specialist, QA Deviation Reviewer job in Summit Full Time

The Sr. Specialist, QA Deviation Reviewer-Approver will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions.
• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job functions.
• Must be action-oriented and customer-focused, building relationships, problem-solving, planning and organizing, resource allocation, and analytical thinking.
• Must possess an independent mindset and tenacity. • Work is self-directed. • Routinely recognizes Quality issues and solves problems.
• Follows established procedures and performs work as assigned.
• Ability to interpret results and situations and articulate recommendations for resolution.
• Capable of providing input within the department and cross-functional teams.
• Builds relationships internally within and with cross-functional teams. • Contributes to goals within the workgroup.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to write and review reports with clarity and brevity.
• Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management. •
• Able to effectively multi-task. • Knowledge of US and global cGMP requirements. •
• Understanding of aseptic manufacturing processes. •
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met. •
• Excellent verbal and written communication skills.

 Education and Experience:

• B.S. degree required; minimum of 3 of experience in the pharmaceutical or related industry.

 DUTIES AND RESPONSIBILITIES:

• Supports all activities for the Quality Operations group.
• Provide quality oversight of Manufacturing Operations, QC Chemistry, and QC Microbiology.
• Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.
• Ensure procedures are adequate to review and confirm the appropriateness of raw data.
• Review and approve manufacturing and QC laboratory investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles. •
• Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.
• Assess global standards/policies and emerging regulations.
• Ensure the site stability program meets global and regulatory requirements.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Able to effectively multi-task.