Specialist, QA Shop Floor

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.

The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing a real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. Must be available to work weekends and off shifts.

Shifts Available:

Wednesday to Saturday OR Sunday to Wednesday - 12-hour shift (every other Wed off)

• 6 a.m. to 6 p.m.

• 4 p.m. to 4 a.m.

• 5 p.m. to 5:30 a.m.

• 5 a.m. to 5:30 p.m.

Responsibilities:

• Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements and resolve issues

• Perform QA shop floor activities, focused on Manufacturing Operations

• Ensure compliance with applicable procedures and production requirements

• Perform real-time review of manufacturing records. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles

• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies

• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.

• Seeks management guidance on complex issues.

• Develops and revise procedures.

Knowledge & Skills:

• Must be action-oriented and skilled in decision-making, building relationships, problem-solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking

• Understands continuous improvement and improves efficiency and productivity within the group or project

• Builds relationships internally within and with cross-functional teams. Contributes to goals within the workgroup

• Ability to direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies

• Possess sound knowledge of FDA-regulated cGMP Quality Manufacturing operations and processes and global cGMP requirements

• Must be skilled in planning and organizing, decision-making, and building relationships

• Knowledge of quality processes, including material disposition, material storage, and handling requirements, change control, product complaints, deviations, investigations, and CAPA management

• Able to recognize conflict and notify management with proposed recommendations for resolution.

• Possess an independent mindset. Work is self-directed

• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision

• Confident in making decisions for non-routine issue

• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution

• Able to prepare written communications and communicate problems to management with clarity and accuracy

• Excellent verbal and written communication skills

Basic Requirements:

• High School Diploma/GED

• At least six months of experience working in a GMP Aseptic manufacturing environment

• Experience in FDA-regulated cGMP Quality Manufacturing operations and processes.

• Available for weekend and off-shift hours

Preferred Requirements:

• Bachelor’s Degree preferred

• 5 years of cGMP Quality Manufacturing operations and processes work experience.

• Quality Assurance Shop Floor Manufacturing roles/experience highly desired (Ex. Quality Operations, In-process QA, IPQA, Quality Inspectors).

Working Conditions:

• Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used.

• Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time.

• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.