Jobs · Analyst · Pennsylvania

QC Lab Team Supervisor

Sanofi · Swiftwater, PA · 4 wk ago
AnalystFull-time
We need to output HTML fragment with sections: About the role? Actually "About the Job" is similar to About the role. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include sections only if posting has real specific content. Let's parse. Job Title: QC Lab Team Supervisor (we do not repeat as heading). Location: Swiftwater, PA (metadata, can be short p). About the Job: paragraph describing role. That's "About the role". So we will have

About the role

then

with that paragraph. Main Responsibilities: list of duties. We'll have

Responsibilities

then
  • each bullet. We need to preserve all substantive info. The responsibilities are broken into sections: Laboratory Operations Management, Compliance & Quality Assurance, Team Leadership & Development, Technical Operations, Laboratory & Quality Systems. Should we keep subheadings? The instruction: use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid subheadings inside? It says use

    for section headings (list). Likely only top-level sections. We can keep subheadings as or maybe as

    but not required. Safer to keep as inside
  • or separate paragraphs. But we need to preserve all info. Could embed subheadings as within
  • . Or we could create separate
      for each subcategory with a preceding

      or

      . However instruction only mentions using

      for those specific section headings; doesn't forbid other headings. But to be safe, we can keep subheadings as inside
    • or as separate

      ...

      before lists. Better: For each major responsibility area, we can have a

      (not prohibited) but they said use

      for section headings (e.g. About the role, Responsibilities...). It doesn't say you cannot use other heading levels. But to avoid risk, we can just use

      Laboratory Operations Management:

      then
        etc. Similarly for Requirements: The posting has "About You:" with Basic Qualifications, Experience, etc. That's qualifications. Also "Technical Skills", "Leadership & Soft Skills", "Health, Safety & Environment (HSE) — Valued Asset". Those could be under Skills or Qualifications. We need to decide sections: Requirements, Qualifications, Skills. The posting includes Basic Qualifications (education + years), Experience (progressive QC experience), Comprehensive knowledge of GMP, Direct hands-on expertise, etc. That's qualifications. Then Technical Skills, Leadership & Soft Skills, HSE. Those could be Skills. We'll create sections: Requirements (maybe combine Basic Qualifications and Experience?), Qualifications (maybe education?), Skills (technical, leadership, HSE). But we must not create thin sections. Let's think. We have content: - Basic Qualifications: Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering or a related scientific field with at least 8 years of experience in a cGMP environment. - Experience: Progressive QC experience within a pharmaceutical or vaccine manufacturing environment, spanning roles from laboratory technician through training management and laboratory management levels - Comprehensive knowledge of GMP and regulatory requirements (FDA, EMA, ICH guidelines) - Direct, hands-on expertise in Particulate Isolation, Micro-FTIR, and SEM/EDS analysis within a regulated pharmaceutical environment - Demonstrated experience authoring and reviewing technical reports, memorandums, and quality documents - Experience in a regulated compendial testing environment (USP/EP/JP standards a plus) - Active involvement in regulatory and internal inspections and audit support activities That's qualifications. Then Technical Skills: Advanced analytical skills..., Proficiency in identifying issues..., Expert knowledge of laboratory instrumentation..., Strong understanding of method validation..., Proficiency in LIMS and quality systems..., Experience with continuous improvement and Lean initiatives... Leadership & Soft Skills: Strong leadership abilities..., Excellent written and verbal..., Keen attention to detail..., Ability to work under pressure..., Strong problem-solving..., Commitment to continuous improvement... Health, Safety & Environment (HSE) — Valued Asset: Experience serving as HSE safety representative..., Demonstrated experience performing monthly GEMBA walks..., Experience facilitating safety initiatives..., Ability to provide safety metrics..., Strong commitment to maintaining a safe laboratory environment... Thus we can have sections: Requirements (maybe combine Basic Qualifications and Experience?), Qualifications (the list of knowledge/expertise), Skills (technical, leadership, HSE). But we need to avoid duplication. Alternatively, we could have one "Requirements" section that includes Basic Qualifications, Experience, Knowledge, Expertise, etc. And a separate "Skills" section for Technical Skills, Leadership & Soft Skills, HSE. That seems reasonable. We also have "Working Conditions" and "Why choose us?" which includes benefits description. Benefits: "Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave." Also mention "Shape the future..." etc. That's more about benefits and culture. We can create a Benefits section with that content. Pay: The posting says "All compensation will be determined commensurate with demonstrated experience." That's vague, not specific. According to instruction: never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Since Pay is only "commensurate with experience", that's filler; we should NOT create a Pay section. Schedule: The posting says "Standard working hours with flexibility based on operational needs, i.e. overtime may be required". That's somewhat specific but still vague. It's not a specific schedule like "Monday-Friday 9-5". It's still somewhat generic but maybe acceptable? The instruction says never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state standard working hours with flexibility, overtime may be required. That's a statement about schedule. So we could include a Schedule section with that sentence. However we need to avoid filler like "varies". This is somewhat specific enough. I'd include Schedule. Benefits: we have content about rewards package, health benefits, parental leave. That's specific enough to include Benefits section. Now we need to ensure we don't include boilerplate like EEO, legal, etc. Remove those. Now produce HTML fragment. Structure:

        Location: Swiftwater, PA

        maybe as metadata. Then

        About the role

        ... paragraph from About the Job.

        Then

        Responsibilities

        then maybe subheadings as

        ...:

        followed by
          . We need to preserve all bullet points. Let's extract responsibilities text: Main Responsibilities: Laboratory Operations Management Oversee daily operations of the quality control laboratory to ensure adherence to committed scheduled plans Conduct routine shopfloor reviews of the laboratory to identify improvement opportunities Ensure accurate and timely testing of received samples according to designated perimeter Assist in scheduling laboratory work to meet the demands of production and operational timelines Serve as a qualified reviewer for key testing areas to maintain operational continuity and testing coverage, including but not limited to: Wet Chemistry, Electrophoresis, HPLC, LCMS, CCIT, BLFG, ICP, FTIR, GC, MALs, and SEM/EDS. Compliance & Quality Assurance Maintain the laboratory in compliance with GMPs and quality control processes defined according to internal and external quality requirements and regulations. Ensure the use of validated methods within the designated perimeter and execute any validation/transfer protocol as receiving unit. Investigate in a timely manner and resolve any quality control events, issues, or discrepancies from the designated perimeter. Implement remediation actions from findings and CAPAs (Corrective and Preventive Actions) Author and review quality documents as a technical reviewer, including procedure revisions, protocols, reports, change controls, CAPAs, and deviations Support internal and external audits through scribing, backroom documentation support, and participation in management walkthroughs for audit preparation and readiness. Investigate customer product complaints and conduct deviation investigations, including interpretation and reporting of results Assist with logbook creation, certification, logbook review, stability dispensing laboratory operations, and file retention management. Team Leadership & Development Manage and train laboratory staff, ensuring they follow best practices and safety guidelines Ensure laboratory staff is qualified to perform testing execution by maintaining the lab qualification matrix Foster a culture of continuous improvement and high performance Oversee training compliance Actively mentor colleagues to support professional development opportunities Participate in the interview and selection process for new hires, including QC production workers, salaried employees, and interns Technical Operations Maintain laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities Ensure lab facilities and instruments are kept in a quality and safety status to ensure appropriate use Apply deep, hands-on expertise in specialized techniques including: **Particulate Isolation and Characterization** using optical microscopy, photographic analysis, and **Micro-FTIR** **FTIR (Fourier Transform Infrared Spectroscopy)** and **SEM/EDS (Scanning Electron Microscopy/Energy Dispersive Spectroscopy)** **Container Closure Integrity Testing (CCIT)** **BLGF Testing** Author technical memorandums and reports Laboratory & Quality Systems Demonstrate proficiency in laboratory and quality management systems including: Opstrakker, Qualipso, iLearn, SAP, LIMS (LabWare), Trackwise, and the Adobe Software Suite We need to keep the bold markup? In HTML we can keep for those. Now About You section: Basic Qualifications Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering or a related scientific field with at least 8 years of experience in a cGMP environment. Experience Progressive QC experience within a pharmaceutical or vaccine manufacturing environment, spanning roles from laboratory technician through training management and laboratory management levels Comprehensive knowledge of Good Manufacturing Practices (GMP) and regulatory requirements (FDA, EMA, ICH guidelines) Direct, hands-on expertise in Particulate Isolation, Micro-FTIR, and SEM/EDS analysis within a regulated pharmaceutical environment Demonstrated experience authoring and reviewing technical reports, memorandums, and quality documents Experience in a regulated compendial testing environment (USP/EP/JP standards a plus) Active involvement in regulatory and internal inspections and audit support activities Technical Skills Advanced analytical skills with the ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement Proficiency in identifying issues and implementing effective solutions to resolve quality control problems Expert knowledge of laboratory instrumentation, maintenance, qualification, and calibration procedures Strong understanding of method validation and transfer protocols Proficiency in laboratory information management systems (LIMS) and quality systems (Trackwise, SAP, iLearn, etc.) Experience with continuous improvement and Lean initiatives, including tracking cost and efficiency metrics, is a differentiating strength (e.g., demonstrated revenue/efficiency performance above target) Leadership & Soft Skills Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standards Excellent written and verbal communication skills Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements Ability to work effectively under pressure and manage multiple priorities Strong problem-solving and critical thinking capabilities Commitment to continuous improvement and quality excellence Health, Safety & Environment (HSE) — Valued Asset Experience serving as an HSE safety representative or correspondent, including conducting regular lab area inspections as preventative actions Demonstrated experience performing monthly GEMBA walks and Satellite Accumulation Area inspections

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