Jobs · Analyst · Pennsylvania

QC Lab Team Supervisor

BioSpace · Swiftwater, PA · 3 wk ago
AnalystFull-time
We need to output HTML fragment with sections: headings using

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections that have real specific content. The posting includes: About The Job (which is like About the role). Then Main Responsibilities (Responsibilities). Then About You (Qualifications? Actually includes Basic qualifications, Experience, Technical Skills, Leadership & Soft Skills, Health, Safety & Environment (HSE) Valued Asset). Then Working Conditions (maybe not a standard heading; but we could treat as part of Requirements? Not needed). Then Why choose us? (Benefits). Also there is mention of compensation: "All compensation will be determined commensurate with demonstrated experience." That's vague; we should not create Pay section because it's not specific (commensurate with experience). So we omit Pay. Schedule: not specific beyond "Standard working hours with flexibility based on operational needs, i.e. overtime may be required." That's somewhat specific but maybe we can include Schedule section? The rule: never create Pay/Schedule/Benefits sections unless posting actually states them. It does state standard working hours with flexibility, overtime may be required. That's schedule info. So we could include a Schedule section with that content. Benefits: "Why choose us?" includes rewards package, health and wellbeing benefits, at least 14 weeks gender-neutral parental leave, etc. That's benefits. So we include Benefits section. We must not repeat job title as heading. No Job ID. Remove boilerplate like EEO etc. Also remove duplicated lines. We need to preserve all substantive information. Use
  • for any list of duties/requirements/benefits, and

    for prose. We need to decide sections: About the role (About The Job), Responsibilities (Main Responsibilities), Qualifications (About You basic qualifications and experience?), Skills (Technical Skills, Leadership & Soft Skills, HSE maybe?), Benefits (Why choose us?), Schedule (Working Conditions). Possibly also a separate section for Requirements? But we have Qualifications covering requirements. The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have About the role, Responsibilities, Qualifications, Skills, Benefits, Schedule. Possibly also Requirements but we can skip if content overlaps with Qualifications. We need to ensure we don't create empty sections. Let's extract content. About The Job paragraph: "The Quality Control Laboratory Team Supervisor plays a pivotal role in ensuring the highest standards of product quality and patient safety within a pharmaceutical/vaccine manufacturing environment. This position is ideally suited for a seasoned QC laboratory professional who has demonstrated progressive growth through hands-on technician roles, training management, and laboratory management responsibilities. The successful candidate will bring proven expertise in quality control operations, regulatory compliance, and team leadership with a track record of driving continuous improvement while maintaining strict adherence to internal and external GMP requirements. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives." We can keep that as prose under About the role. Responsibilities: Main Responsibilities includes several bullet-like sentences. We need to convert to

    • . The text includes headings like Laboratory Operations Management, Compliance & Quality Assurance, Team Leadership & Development, Technical Operations, Laboratory & Quality Systems. We could treat each as a subsection but we only need

      for section headings, not subheadings. We can just list all responsibilities as list items. However we need to preserve all substantive information; we can keep the headings as part of list item text. Let's extract each responsibility sentence. From text: "Laboratory Operations ManagementOversee daily operations of the quality control laboratory to ensure adherence to committed scheduled plansConduct routine shopfloor reviews of the laboratory to identify improvement opportunitiesEnsure accurate and timely testing of received samples according to designated perimeterAssist in scheduling laboratory work to meet the demands of production and operational timelinesServe as a qualifiedreviewer forkey 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." That seems like a run-on; we need to split into sensible items. Could break by verbs. Better to keep as a paragraph? But rule: Use
      • for any list of duties/requirements/benefits. So we should make each duty a list item. We can parse: - 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. Next section: 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 deviationsSupport 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 resultsAssist with logbook creation, certification, logbook review, stability dispensing laboratory operations, and file retention management." We can split similarly. Team Leadership & Development: "Manage and train laboratory staff, ensuring they follow best practices and safety guidelinesEnsure laboratory staff is qualified to perform testing execution by maintaining the lab qualification matrixFoster a culture of continuous improvement and high performanceOversee training complianceActively mentor colleagues to support professional development opportunitiesParticipate 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 activitiesEnsure lab facilities and instruments are kept in a quality and safety status to ensure appropriate useApply deep, hands-on expertise in specialized techniques including:**Particulate Isolation and Characterization** using optical microscopy, photographic analysis, and **Micro-FTIR****FTIR (Fourier Transform InfraredSpectroscopy)** and **SEM/EDS (Scanning Electron Microscopy/Energy DispersiveSpectroscopy)****Container Closure Integrity Testing (CCIT)****BLGF Testing**Author technical memorandums and reports" Note there is some formatting with **. We'll keep the text. Laboratory & Quality Systems: "Demonstrate proficiency in laboratory and quality management systems including:Opstrakker,Qualipso,iLearn, SAP, LIMS (LabWare),Trackwise,**and the **Adobe Software Suite**" Now About You section: Basic qualifications: Bachelors 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 levelsComprehensive 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 environmentDemonstrated experience authoring and reviewing technical reports, memorandums, and quality documentsExperience in a regulated compendial testing environment *(USP/EP/JP standards aplus)*Active involvement in regulatory and internal inspections and audit support activities Technical Skills: Advanced analytical skills with the ability toanalyzecomplex data and laboratory results to make informed decisions and identify areas for improvementProficiency in identifying issues and implementing effective solutions to resolve quality control problemsExpert knowledge of laboratory instrumentation, maintenance, qualification, and calibration proceduresStrong understanding of method validation and transfer protocolsProficiency 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 abovetarget)* Leadership & Soft Skills: Strong leadership abilities to manage and motivate a team, ensuring high performance and adherence to quality standardsExcellent written and verbal communication skillsKeen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirementsAbility to work effectively under pressure and manage multiple prioritiesStrong problem-solving and critical thinking capabilitiesCommitment 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 actionsDemonstrated experience performing monthly **GEMBA walks** and **Satellite Accumulation Area inspections**Experience facilitating safety initiatives, presenting safety communications, and driving action item completion within a QC departmentAbility to provide safety metrics for department-level meetings (L1, L2, QDCI) and serve as backup to the QC HSE managerStrong commitment to maintaining a safe laboratory environment as a core operational priority Working Conditions: Laboratory environment with exposure to chemicals and specialized equipmentMay require the use of personal protective equipment (PPE)Standard working hours with flexibility based on operational needs, i.e. overtime may be required Why choose us? (Benefits): Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.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 andwellness programs and at least 14 weeksgender-neutral parental leave.Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scaleTransform lives worldwide by delivering life-changing treatments anywhere, anytime. We need to output HTML fragment only. We'll create sections:

        About the role

        ... (the About The Job paragraph)

        Responsibilities

        • 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.
        • 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

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