Senior Specialist, QA Manufacturing Shop Floor, Cell Therapy (Manufacturing Operations)

Bristol Myers Squibb•Devens, MA

7d•$89,780 - $108,789•Onsite

About The Position

Bristol Myers Squibb is seeking experienced candidates to provide direct Quality Assurance support to GMP manufacturing operations. The successful candidate will support production activities on the manufacturing floor and partner with operators, supervisors, and manufacturing leadership. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The Senior Specialist will serve as a Quality Representative interacting with Manufacturing, Supply Chain, Quality Control, and other supporting functions. This role is accountable for quality decision-making related to unexpected events on the production floor, deviation triage, and determination. Participation in cross-functional triage meetings is expected. The role involves reviewing or quality approving GxP records, including procedures, batch records, or deviations. Additionally, the incumbent will support deviation approval, alarm approval, and other Quality System Records as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for success in this role. This position reports to the Shift Manager, Quality Assurance Shop Floor and works a rotating 2-3-2 Panama schedule (6am to 6pm) Day shift.

Requirements

Direct QA experience providing direct Quality Assurance support to GMP manufacturing operations.
Ability to research, understand, interpret and apply internal SOP’s, policies and regulatory guidelines.
Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications.
Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
Excellent written and verbal skills and ability to present technical data effectively based on target audience.
Ability to work in a fast-paced team environment and lead peers through changing priorities.
Detail oriented and task focused with ability to meet deadlines and support work prioritization.
Ability to negotiate and influence to craft mutually beneficial solutions.
Ability to motivate and foster a positive team environment.
Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
Pioneering mindset and ability to create innovative solutions.
Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Demonstrated experience with quality management systems
Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.

Nice To Haves

Bachelor's degree in STEM field preferred.
High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.

Responsibilities

Provide Quality oversight to Manufacturing/QC/Warehouse/ Packout operations.
Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.
May perform and document operational verification per approved procedures.
Develops, reviews and/or approves temporary and non routine procedure for event response.
Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
Own actions for departmental programs and propose improvements to programs.
Participate in Gemba walks.
Communicate and resolve discrepancies independently and escalate as required.
Author, review, and approve procedural documents.
Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.
May own training curriculum and content.
May present individual topics during audits as needed.
Independently assess discrepancies for entry into quality system and approve deviations as applicable.
May serve as quality subject matter expert for risk assessments, change controls, etc.
Lead meetings and represent function at cross functional meetings.
Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.
May prioritize and assign tasks for the team.
Periodically observe operations occurring on the floor and proactively identify risks and drive improvements.
Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
Functions as a project manager able to influence others based on time and task commitments, organize/run meetings.
Obtain access to, and develop as an SME for, various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).
Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.
Share data/knowledge within and across teams by acting as a champion for quality-culture and learning.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval)
11 paid national holidays
160 hours annual paid vacation for new hires with manager approval
11 national holidays
3 optional holidays
Unlimited paid sick time
Up to 2 paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day.