Specialist, Field Quality

Bristol-Myers Squibb Co; Harvard (MA); On-site; USD 82,000 - 99,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Disability & life insurance

Job summary

Bristol Myers Squibb is hiring a Specialist, Field Quality to provide quality oversight for in-process materials, intermediates, and manufactured products. You will review documentation and support investigations to ensure compliance with cGMPs and company standards.

The role involves QA floor support, batch record reviews, and participation in inspections readiness. A BS in a science-related field and 2 years in a regulated environment are preferred, with comprehensive benefits offered.

Qualifications

• B.S. in science, engineering, biochemistry or related discipline preferred.
• 2 years' relevant experience in a regulated environment or mix of Co-Op and regulated environment preferred.
• Knowledge of US/EU cGMP regulations and guidance.

Responsibilities

• Quality floor support for manufacturing activities.
• Review batch production records for media/buffer/cryo in support of product release.
• Perform GMP walkthroughs and inspections readiness.
• Support return-to-service walkthroughs and manufacturing inspection readiness.
• Ensure all documentation requiring QA review complies with cGMP and site procedures.
• May support quality review of manufacturing deviations and release of products.
• QA floor support activities including alarm and logbook reviews.
• Other duties as assigned.

Skills

Biotech manufacturing knowledge

cGMP awareness

Documentation mindset

Education

B.S. in science / engineering / biochemistry or related

Tools

MS Word

Excel

DeltaV

Electronic batch records

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Summary: Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Major Duties and Responsibilities

• Quality floor support for minor and routine manufacturing activities
• Performs routine manufacturing batch production record review for media/buffer/cryo in support of product release in accordance with specifications and SOPs.
• Perform walkthroughs of GMP areas documenting observations and areas of concern.
• Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
• Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
• May support the Quality review of manufacturing deviations.
• May support release of incoming or manufactured products
• Routine QA Floor Support Activities, including but not limited to alarm review, logbook review, etc.
• Other duties as assigned

Knowledge and Skill

• Knowledge of biotech bulk and finished product manufacturing, analytical testing is desirable.
• Familiarity with US and EU cGMP regulations and guidance.
• Working knowledge of common computer systems such as MS-Word and Excel is required.
• Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking, and maintenance is desirable.

Qualifications

• A B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A combination of 2 years relevant experience in a regulated environment or mix of Co-Op and regulated environment is preferred

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Devens - MA - US: $81,800 - $99,117

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1608024 : Specialist, Field Quality