Senior Specialist, QA Shop Floor

We need to output HTML fragment with sections: About the role? The posting includes a paragraph about culture and purpose, then Position Summary, then Duties/Responsibilities, Qualifications, Compensation Overview (Pay), Benefits, How We Work (maybe not needed unless specific content), Supporting People With Disabilities, Candidate Rights, Data Protection etc. But we must only include sections when posting has real, specific content for it. We should not include sections like "How We Work" if it's generic? It does have content: description of work models and link. That could be considered a section maybe "Work Model". However the instruction says use headings for section headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. It doesn't list "How We Work" etc. So we should stick to those headings only if content exists. We have content for About the role (the initial paragraph about culture and purpose). We have Responsibilities (Duties/Responsibilities). We have Requirements/Qualifications (Qualifications). We have Skills (maybe part of Qualifications but we could separate? The instruction says we can use Skills heading if there is specific content. The Qualifications section includes skills. Could combine Qualifications and Skills? Better to have Qualifications heading covering education/experience/licenses, and Skills heading for abilities. But we need to avoid thin sections. Let's see: The Qualifications section includes "Specific Knowledge, Skills, Abilities:" then list of abilities, then "Education/Experience/ Licenses/Certifications:" then list. So we could split into Skills and Qualifications. That seems reasonable. We have Pay: Compensation Overview with salary range. We have Benefits: Benefits section. We have Schedule: The posting includes "Available Shifts" list. That's schedule info. So we should include Schedule section. We should not include sections like "How We Work", "Supporting People With Disabilities", etc unless they map to headings we have. They don't. So we drop them. We must not repeat job title as heading. So no heading for Senior Specialist, QA Shop Floor. We must not include Job ID/requisition numbers as headings; we can drop them or put in short p. Probably drop. We must preserve all substantive information; do not invent or summarize away detail. So we need to include all details from the sections we keep. We need to format: headings

. Use

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

  for prose. We need to ensure we include all duties/responsibilities as list items. The duties are a long paragraph with many sentences separated by periods. We need to convert each duty into a list item? The instruction: Use

  • for any list of duties/requirements/benefits. So we should turn the duties into a list. Similarly for qualifications/skills/benefits. We need to be careful not to lose any detail. Let's extract. First, About the role: The initial paragraph before Position Summary: "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." We'll put that in a

    under

    About the role

    . Next, 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." This could be part of About the role or Responsibilities? It's a summary; we could include it under About the role as additional prose, or maybe under Responsibilities. But we already have About the role; we could add this as another paragraph under same heading. However instruction: Prefer a few substantive sections over many thin ones. So we can keep About the role with both paragraphs. Then Responsibilities: We need to list each duty as
  • . Let's extract sentences: - Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/ Packout operations/Label Operations. - Identify departures from approved procedures and respond to complex issues independently and escalating 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. - Provide quality oversight to non-routine maintenance work. - Review and approve return to service plans. - Coordinate and lead area walkthroughs to identify quality issues. - Negotiate remediations and drive alignment of implementation plans. - Own shift actions for departmental programs and propose improvements to programs. - Participate in Gemba walks. - Review manufacturing or testing records to ensure compliance with approved procedures. - 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. - 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. We need to keep all details. Some sentences have slashes; keep as is. Now Qualifications/Skills. We have "Specific Knowledge, Skills, Abilities:" list: - Ability to research, understand, interpret and apply internal 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. Then "Education/Experience/ Licenses/Certifications:" list: - Bachelor's 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+ years 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 with electronic systems and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP), etc. - 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 could split into Skills heading for the first list, and Qualifications heading for the second list (education/experience). That seems appropriate. Now Pay: Compensation Overview: "Summit West - NJ - US: $83,900 - $101,671 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'll put that in

    under

    Pay

    . Also maybe include the location? It's part of the line. Now Benefits: The 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'll put that as
    • for each distinct benefit? Could be a list. But the instruction: Use
      • for any list of duties/requirements/benefits. So we should turn the benefits into list items. However the paragraph includes multiple sentences; we can split into logical items. Let's extract benefit items: - 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 eligible for Flexible Time Off (FTO): paid time off without a set accrual limit, subject to manager approval, plus 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, access to additional time-off benefits: paid sick leave, up to two paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. - Eligible employees 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'll keep each as
      • . Now Schedule: Available Shifts list: "Available Shifts M-F 5pm-1am (swing)S-W 5pm-5am (Quad 2)M-F 9am-5pm (day)W-S 5am-5pm (Quad 3)". This seems messy; we need to preserve as is. Could format as list: - M-F 5pm-1am (swing) - S-W 5pm-5am (Quad 2) - M-F 9am-5pm (day) - W-S 5am-5pm (Quad 3) We'll put under <