QA Specialist, Batch Record Review

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.

PURPOSE AND SCOPE OF POSITION:

The Specialist is responsible for Batch Record Review quality activities in accordance with BMS policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring accurate and timely maintenance and review of manufacturing batch record documentation and department procedures and SOPs.

(Wed-Sat 1st Shift 7:00am - 5:30pm)

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Able to prepare written communications and communicate problems to Supervisors with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

Education and Experience:

• B.S degree with minimum of 3 years GMP experience in the Pharmaceutical or related industry.
• Batch Record Review experience is highly preferred.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Responsible for the review and approval of executed batch records.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including change control, deviations, investigations and CAPA management.
• Own change control, deviation and CAPA quality system records on behalf of the department, as needed.
• Contributes to the goals within the work group.
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
• Initiates and revises department SOPs.
• Supports inspection readiness and acts as Subject Matter Expert during compliance audits and regulatory inspections.
• Able to effectively multi-task.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.