Senior Specialist, Quality Assurance Training

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 (Position Summary):

The Quality Assurance Training Senior Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include oversight of training and timely qualification of Quality Associates on all processes, procedures, and practices necessary to support product manufacturing and product disposition, as well as meet cGMP and internal standards.

In addition to onboarding coordination and training of new hires, the QA Training Senior Specialist will also be responsible for training curriculum management in accordance with training policies and procedures, change control/CAPA action ownership related to training, review and revision of cGMP Controlled Documents related to training, and supporting routine clinical and commercial activities related to QA to ensure consistent compliance with regulatory and industry expectations.

This role directly supports Jump’s release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Jump with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment.

This Position qualifies for a $10,000 Sign-on Bonus, $5,000 payable within 30 days of start date and $5,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.

QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):

Education:

Bachelor’s degree in relevant science or engineering discipline is preferred. Minimum of an Associates degree and/or equivalent combination of education and experience is required.

Experience:

• 5-8 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals, cell therapy manufacturing, or quality control is preferred.
• Experience working with Subject Matter Experts and translating content and performance requirements into sound training content.
• Knowledge of adult learning methods, strategies, and techniques.
• Excellent written, verbal, and presentation skills.
• Strong communication, analytical, and problem-solving skills.

• Demonstrated ability to interface, coach, and influence.
• Knowledge of learning management systems and web delivery tools
• Ability to receive and provide feedback in a constructive way.
• Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
• Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
• Knowledge of cGMP regulations and FDA, EU, ICH guidance applicable to biologics and cell therapy manufacturing/quality control.
• Strong computer skills with Word and Excel and other electronic manufacturing systems.
• Detail oriented team player with effective time management, planning, organization, and execution skills.
• Proven experience working on teams where combined contribution, collaboration, and results were expected.
• Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
• Ability to work in a fast-paced team environment.
• Ability to manage multiple priorities simultaneously, have a strong drive orientated on results.

License/Certifications:

N/A

ROLES AND RESPONSIBILITIES:

• Maintain, evolve, and improve the training lifecycle program for QA Ops On-The-FloorTF Team to ensure compliance with approved procedures.
• Support and lead the training and on-boarding of all QA associates for the QA Ops On-The-Floor Team for all tasks including but not limited to facilitating system access, navigation of systems, batch record review, product receipt, product packaging, gowning, deviations, and document review.
• Support and own necessary change control and CAPA actions related to revision of training procedures and curriculums.
• Own, Revise, and Approve Standard operating Procedures and training documents as needed.
• Conduct Quality on the Floor activities including quality walk-throughs of the manufacturing, QC areas, and warehouse locations.
• Act as QA Subject Matter Expert (SME) and support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
• Lead small to large scope projects as assigned.
• Participate in small and large cross functional project groups as QA Subject Matter Expert (SME), related to training.
• Support internal and external audits, including documenting observations and oversee implementation of corresponding CAPAs.
• May provide support to QA Ops OTF department when available and participate in tasks including but not limited to batch record review, product receipt, product packaging, deviations, and document reviews.
• May Own, Review, and approve deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs).

TRAVEL REQUIREMENTS:

☒ Not Applicable

WORKING CONDITIONS (US Only):

• While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
• May work in areas with exposure to vapor phase liquid nitrogen and other chemicals.
• Must be able to gown per requirements to enter manufacturing space.
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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.