Jobs · Quality Assurance · Massachusetts

Senior Specialist, QA Shop Floor

Bristol Myers Squibb EU Policy · West Summit, MA · 4 wk ago
Quality Assurance$84k–$102k/yrFull-time
We need to output HTML fragment with sections: Use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title as heading. We need to include sections only when posting has real specific content. We need to parse the posting for content. First, there is introductory paragraph about BMS culture etc. That could be "About the role" or maybe "About the company". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can use "About the role" for the introductory description. Then "Position Summary" and "Duties/Responsibilities" -> that is responsibilities. Then "Qualifications" includes Specific Knowledge, Skills, Abilities and Education/Experience/Licenses/Certifications. We can separate into Requirements (maybe) and Qualifications? The instruction says we can have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what to put where. We have "Specific Knowledge, Skills, Abilities:" which is skills. Also "Education/Experience/Licenses/Certifications:" which is qualifications/requirements. We also have "Compensation Overview" with pay range -> Pay section. We have "Benefits" section -> Benefits. We have "Available Shifts" list -> Schedule. We also have "How We Work", "Supporting People With Disabilities", "Candidate Rights", "Data Protection" etc. Those are boilerplate; we should remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should omit those. Thus final HTML should contain sections: About the role (intro), Responsibilities (duties), Requirements (maybe education/experience?), Qualifications (maybe specific knowledge?), Skills (maybe we can combine). But we need to avoid thin sections. Perhaps combine Requirements and Qualifications into one? But instruction says we can have multiple sections; we prefer few substantive sections over many thin ones. So we could combine education/experience and specific knowledge into a "Qualifications" section, and maybe have a "Skills" section for the specific knowledge, skills, abilities list. Or we could have "Requirements" for education/experience, and "Qualifications" for specific knowledge, skills, abilities. Then we could have a separate "Skills" maybe redundant. Better to have: About the role, Responsibilities, Qualifications (covering education/experience and specific knowledge), Benefits, Pay, Schedule. That's 5 sections. But we need to follow headings list: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can omit those we don't have content for. So we can include About the role, Responsibilities, Qualifications, Benefits, Pay, Schedule. Omit Requirements and Skills if we merge into Qualifications. Check if we have content for Skills: The "Specific Knowledge, Skills, Abilities:" list is definitely skills. Could put under Skills heading. But then we would also need Qualifications for education/experience. That would be two sections: Skills and Qualifications. That's okay; both substantive. Thus sections: About the role, Responsibilities, Skills, Qualifications, Benefits, Pay, Schedule. We must not repeat job title as heading. No Job ID/requisition as heading. We need to use

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

    for prose. We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to include all details from the posting, but we can format them. We need to remove boilerplate: The introductory paragraph about BMS culture is substantive? It's about company purpose; we can keep as About the role. Position Summary: we can include as part of About the role or Responsibilities? Probably About the role includes position summary. Duties/Responsibilities: we need to list each duty as

  • under a
      . The duties are many sentences; we need to split into list items. We must preserve all detail; we can break at each sentence or each duty bullet. The original text is a paragraph with sentences separated by periods. We'll make each sentence a list item. Qualifications: we have "Specific Knowledge, Skills, Abilities:" list; we can put under Skills heading as list. Education/Experience/Licenses/Certifications: we can put under Qualifications heading as list (or prose). We'll make list. Benefits: we have a paragraph describing benefits; we can keep as

      under Benefits heading. Pay: we have compensation overview with pay range and description; we can put as

      under Pay heading. Schedule: we have "Available Shifts" list with shift times; we can put as

      • each shift. We must not include duplicated lines, cookie/navigation/legal/EEO etc. So we will omit sections like "How We Work", "Supporting People With Disabilities", "Candidate Rights", "Data Protection", etc. Also we need to omit the "We hire for skills and capabilities..." paragraph? That is part of Qualifications? It's a statement encouraging applicants; maybe we can keep under Qualifications as prose? It's substantive but maybe not required. The instruction says preserve ALL substantive information; do not invent or summarize away detail. So we should keep it. It's under Qualifications maybe as a

        . Also the "Compensation Overview" includes note about discretionary incentive cash and stock opportunities, etc. Keep. Also the "Benefits" includes details about FTO, holidays, etc. Keep. Also the "How We Work" etc we remove. Also the "Supporting People With Disabilities", "Candidate Rights", "Data Protection", "Visit careers.bms.com/eeo-accessibility", etc. Remove. Also the "Any data processed..." etc remove. Also the "If this posting is missing required information..." remove. Also the "Do not send application-related inquiries..." remove. Also the "To check your application status..." remove. Also the "R1606925 : Senior Specialist, QA Shop Floor" at end is Job ID; we should not put as heading; we can drop it. Now produce HTML. Structure:

        About the role

        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.

        But we need to avoid repeating "Position Summary" as heading; we can keep as part of paragraph. Now Responsibilities:

        Responsibilities

        • 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.
        Now Skills:

        Skills

        • 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.
        Now Qualifications:

        Qualifications

        • 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.

        Now Benefits:

        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

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