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Senior Specialist, Quality Assurance Shop Floor, Cell Therapy
Senior Specialist, Quality Assurance Shop Floor, Cell TherapyBristol Myers Squibb • Devens, Massachusetts, USA
Senior Specialist, Quality Assurance Shop Floor, Cell Therapy

Senior Specialist, Quality Assurance Shop Floor, Cell Therapy

Bristol Myers Squibb • Devens, Massachusetts, USA
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Working with Us

Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more : Summary : The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations including but not limited to Manufacturing Quality Control laboratories and Warehouse Operations.

This position works a Monday to Friday schedule Day shift. This position will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies standards procedures and Global cGMP.

In the capacity of Shop Floor QA the Senior Specialist shall serve as one of the Shop Floor Representatives interacting with Manufacturing Supply Chaing Quality Control and other supporting teams.

The Senior Specialist Shop Floor QA is accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own review or approve Floor Quality GxP records including but not limited to procedures CAPAs change controls impact assessments documentation or deviations; and represents SFQA at relevant governance forums. Additionally the incumbent shall to support deviation approval alarm approval other Quality System Records or batch record review as requested by management. Effective communication critical thinking and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

This position reports to the Senior Manager Quality Assurance Shop Floor Monday to Friday Team. This is an individual contributor role working Monday to Friday.

Key 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 Shop Floor Quality (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.

Qualifications & Experience :

Specific Knowledge Skills Abilities :

  • Demonstrated experience with quality management systems for handling of records such as change control product complaints deviations investigations and CAPA management.
  • Ability to research understand interpret and apply internal SOPs 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.
  • Demonstrated ability to learn and work with analytical computer / digital tools like Microsoft Power Automate Smartsheet Tableau etc.
  • Education / Experience / Licenses / Certifications :

  • Bachelors degree in STEM field preferred. High school diploma / Associates degree with equivalent combination of education and work experience may be considered.
  • 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.
  • The starting compensation for this job is a range from $94550 - $ 114600 plus incentive cash and stockopportunities (based on eligibility).

    The starting pay rate takes into account characteristics of the job such as required skills and where the job is performed.

    Final individual compensation will be decided based on demonstrated experience.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit our BMS Careers Site.

    Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medicalpharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplementalhealth insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidaysGlobal Shutdown days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility / infertility benefits support for traveling mothers and child elder and pet care resources. Other perks liketuition reimbursement and a recognition program.

    BMSCART #LI-Onsite

    GPS2025

    If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

    Compensation Overview :

  • Devens - MA - US : $89780 - $108789
  • The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility / infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    Uniquely Interesting Work Life-changing Careers

    With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol

    BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

    Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

    If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information : data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

    Required Experience :

    Senior IC

    Key Skills

    Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Monthly Salary Salary : 89780 - 108800

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