Jobs · Quality Assurance · Massachusetts

Specialist QA Shop Floor

Bristol Myers Squibb EU Policy · West Summit, MA · 1 mo ago
Quality Assurance$34.92–$42.32/hrFull-time
We need to output HTML fragment with sections: About the role? The posting includes a paragraph about company purpose, then Position Summary, then Shifts, then Duties/Responsibilities, then Reporting Relationship, then Qualifications (Specific Knowledge, Skills, Abilities, Education/Experience/Licenses/Certifications), then Compensation Overview (pay range), then Benefits, then How We Work (maybe not needed), then Supporting People With Disabilities, Candidate Rights, Data Protection etc. We must remove boilerplate like EEO, legal, scam warning, duplicated lines, application instructions. Also we should not repeat job title as heading. No Job ID/requisition numbers as headings; fold minor metadata into short p or drop it. We need to preserve all substantive information. We need to decide which sections to include: About the role (maybe the introductory paragraph about company purpose and culture). Responsibilities (Duties/Responsibilities). Requirements/Qualifications (Qualifications). Benefits (Benefits). Pay (Compensation Overview). Schedule (Shifts). Possibly also "How We Work" but that's more about work models; could be considered part of About the role? Might be optional. The instruction: Prefer a few substantive sections over many thin ones. Include a section ONLY when posting has real, specific content for it. So we can include sections: About the role (intro paragraph), Responsibilities, Requirements, Benefits, Pay, Schedule. Possibly also "Qualifications" as Requirements. We'll combine Education/Experience etc under Requirements. We must not include headings with filler like "commensurate with experience". Not present. We need to use

for section headings. Use
  • for any list of duties/requirements/benefits. Use

    for prose. We need to preserve all substantive information: That includes the company purpose paragraph, the Position Summary, the Shifts details, the Duties/Responsibilities bullet list (though it's paragraph sentences, not explicit list; but we can convert to

    • each duty? The instruction: Use
      • for any list of duties/requirements/benefits. The duties are given as sentences separated by periods; we can treat each sentence as a list item. That seems appropriate. Similarly for Qualifications: list of skills, abilities, education/experience. We'll convert each bullet point into
      • . Benefits: paragraph describing benefits; we can keep as

        maybe with some list? It includes multiple items; we could make a list. Pay: we have compensation overview with pay range; we can put in

        . Schedule: Shifts: multiple shifts open etc; we can put in

        or list. We must not include duplicated lines. Ensure we don't include boilerplate like "We hire for skills and capabilities..." that's substantive? It's part of qualifications; we keep. We must not include job ID/requisition numbers as headings; we can include them in a short p at end maybe? The instruction: fold minor metadata into a short

        or drop it. The Job ID is at end: "R1606599 : Specialist QA Shop Floor". We can drop it or put in a small p. Probably drop it as minor metadata. We must not include application instructions like "To check your application status..." etc. Remove those. We must not include cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So remove sections: Supporting People With Disabilities, Candidate Rights, Data Protection, etc. Also remove "How We Work" maybe? It's not boilerplate but could be considered substantive? It's about work models; could be part of About the role. But to keep few sections, we might omit it. We must preserve all substantive information: The "How We Work" paragraph includes info about work models; is that substantive? Possibly yes, but we can incorporate into About the role? The instruction: Prefer a few substantive sections over many thin ones. Could merge How We Work into About the role as extra paragraph. But we need to decide. Better to keep About the role (company purpose + position summary + how we work). Responsibilities, Requirements, Benefits, Pay, Schedule. Let's extract substantive content: Company purpose paragraph: "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." Position 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, Label Operations and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP." Shifts: "Shifts: Multiple Shifts Open Sun-Wed Days - 5:00am-5:30pmWed-Sat Days - 5:00am-5:30pmSun-Wed Nights - 5:00pm-5:30amWed-Sat Nights- 5:00pm-5:30am" We need to keep that exactly. Duties/Responsibilities: list of sentences: - Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, Label Operations and Supply Chain operations. - Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy. - Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members. - Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures. - Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques. - Provide quality oversight for pre-planned return to service plans. - Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners. - Identify and propose improvements to programs, procedures, and practices. - Review manufacturing batch records to ensure compliance with approved procedures. - Review and provide feedback on documents such as forms, logbooks, and procedures. - Maintain compliance with assigned learning plan. - Provide integration support of newer team members. - Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge - Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. - Participate in quality and shift meetings. - Build and maintain relationships with core partner functions and seek collaborative solutions. - Share data/knowledge within team by acting as a champion for quality-culture. - For markets requiring an Authorized Person (AP) release to be performed by Summit, act as designated AP performing Certification/Release for Supply in accordance with the PIC/S Guide to GMP (including Annex 16) and any local market requirements e.g. Australian Therapeutic Goods Administration (TGA) requirements, including the Therapeutic Goods Act 1989 and associated GMP principles. - Perform verification and reconciliation of issued drug product labels. Reporting Relationship: "Reporting Relationship Reports to the Manager, Quality Assurance Shop Floor" Could be included under Responsibilities or as separate line; but we can incorporate as a sentence in Responsibilities maybe. But we can keep as a short p under Responsibilities? Probably we can include as a bullet under Responsibilities: "Reports to the Manager, Quality Assurance Shop Floor". However the instruction: Use

        • for any list of duties/requirements/benefits. Reporting relationship is not a duty but could be included as a duty? Might be okay to include as a bullet. Qualifications: Specific Knowledge, Skills, Abilities list: - Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking. - Ability to understand, follow, and apply internal policies, procedures, and quality principles. - Prior experience with quality processes, including but not limited to batch record review, change control, product complaints, deviations, investigations, and CAPA management. - Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions. - Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work. - Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints. - Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills. - Active listening skills to understand diverse working perspectives. - Contributes to a positive team environment. - Able to independently make decisions based on data and facts, and recognizes when to escalate - Seeks opportunities for improvement to quality and operational problems. - Ability to work within pharmaceutical cleanroom environments. - Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management. - Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. - Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. - Education/Experience/Licenses/Certifications: - Bachelor's degree in STEM field. - High school diploma or associate’s degree with equivalent combination of education and work experience is considered. - 2+ years of relevant cGMP experience with 1+ years of manufacturing site experience. - Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. - 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. We need to keep that. Benefits: paragraph: "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" We can keep as

          or maybe break into list but it's okay as paragraph. Compensation Overview: "Compensation Overview Summit West - NJ - US: $34.92 - $42.32per hour 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." We can keep as

          . Schedule: Already have Shifts paragraph. We also have "How We Work" paragraph: "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

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Specialist QA Shop Floor

Bristol Myers SquibbSummit, NJ· 1 mo ago
Quality Assurance$34.92–$42.32/hrapply on tnl2.jometer.com