Jobs · Quality Assurance · New Jersey

QC Specialist, Lab Services I

Legend Biotech · Raritan, NJ · 1 mo ago
On-siteQuality Assurance$63k/yrFull-time
We need to output HTML fragment with sections: About the role? Actually we need to use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include only sections that have real specific content. We need to preserve all substantive info, not invent. We have job posting content: includes company description, role overview, responsibilities, requirements, shift schedule, location, travel, lifting, pay range, benefits, etc. We need to format into semantic HTML:

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

    for prose. We must not repeat job title as heading. Do not put Job ID/requisition numbers as headings. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. So we need to strip out EEO statement, work authorization, privacy notice, etc. Also remove "Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech." That's maybe part of benefits but could be kept? It's a note about eligibility; might be considered boilerplate? It's not EEO but still a note. Might keep? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The note about benefits eligibility is not exactly those categories, but could be considered legal? It's about benefits eligibility; maybe keep as part of benefits section. However we can keep if it's substantive. We'll decide to keep it as part of benefits. We need to include sections only when posting has real specific content. So we need sections: About the role (maybe from Role Overview), Responsibilities, Requirements, Qualifications? The posting includes Requirements (list) and also mentions degree etc. Could treat Requirements as qualifications. There's also Skills (maybe Microsoft Office, LIMS). Benefits, Pay, Schedule (shift schedule). Also maybe Location? Not a heading we have; we could include under About the role or maybe not needed. The instruction only lists those headings; we should not add others. So we can embed location etc in prose under About the role or Responsibilities. We must not create Pay/Schedule/Benefits sections unless posting actually states them. It does state Pay range, Benefits, Shift schedule (Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process.) So we include those. We need to preserve all substantive info: company description, role overview, responsibilities list, requirements list, shift schedule, location, travel, lifting, pay range, benefits details. We must not invent or summarize away detail. So we need to keep specifics like "up to 5% of travel", "occasionally require to lift up to 20 pounds", "base pay range $63,298 USD - $83,077 USD", benefits list. We need to format lists with

    • . For responsibilities: list each bullet. For requirements: list each bullet. For benefits: list each bullet. We need to use

      for prose paragraphs. We must not include markdown code fences. Just raw HTML. Let's extract sections: About the role: Could combine company description and role overview. The role overview: "The QC Specialist, Lab Services, is responsible for sample management...". Also includes "Role Overview The QC Specialist, Lab Services, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively." Also company description at start: "Legend Biotech is a global biotechnology...". That could be part of About the role. We'll create

      About the role

      then a

      containing company description and role overview combined. Responsibilities: list bullet points from "Key Responsibilities". Let's extract each: - Prepares and reviews documentation independently. - Responsible for QC sample and retain management. - Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems. - Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS). - Prepare documents and coordinate Sample shipment (internal and external shipments). - Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators. - Periodic inspection and consolidation of retains. - Document and perform sample management related non-conformance investigations. - Document and handle corrective and preventative action records. - Supports internal and regulatory audits. We need to keep exact phrasing. Requirements: list bullet points from "Requirements". Let's extract: - A minimum of a Bachelor’s degree or higher. - A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry. - A degree in Biology, Biochemistry, Microbiology, Chemistry or related field. - Solid understanding of regulatory requirements, policies and guidelines. - Experience with Quality Control document reviews and regulatory inspection processes. - Working knowledge of Quality systems. - Experience in management of retain samples using electronic systems (eLIMS). - Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process. - This position will be located in Raritan, NJ and may require up to 5% of travel. - This position will occasionally require to lift up to 20 pounds. Note: The shift schedule and location/travel/lifting are also in requirements but could be placed under Schedule section. However we have a Schedule heading; we could move shift schedule details there. But the instruction says include a section ONLY when posting has real specific content for it. So we can have Schedule section with shift schedule details. The location/travel/lifting could be part of About the role or maybe a separate section not listed; we could embed in About the role. We need to avoid duplication. If we put shift schedule in Schedule section, we should not duplicate it in Requirements. So we should remove shift schedule bullet from Requirements and place it under Schedule. Similarly location/travel/lifting could be placed under About the role or maybe a separate "Location" but not in allowed headings. So we put in About the role. Thus Requirements list will exclude shift schedule bullet. Now Benefits: list bullet points from benefits paragraph. Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs. We need to break into list items. Could list each benefit as separate

    • . But we must preserve all substantive info; we can group similar items but better to list each distinct benefit. Let's extract: - Medical insurance - Dental insurance - Vision insurance - 401(k) retirement plan with company match that vests fully on day one - Eight (8) weeks of paid parental leave after three (3) months of employment - Paid time off policy includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays - Flexible spending accounts - Health savings accounts - Life insurance - AD&D insurance - Short-term disability coverage - Long-term disability coverage - Legal assistance - Supplemental plans: pet insurance, critical illness insurance, accident insurance, hospital indemnity insurance - Voluntary commuter benefits - Family planning and care resources - Well-being initiatives - Peer-to-peer recognition programs Also note: "Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech." Could be a note; we could add as a

      after list. Pay: base pay range: $63,298 USD - $83,077 USD. Also Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. We need Pay section with those details. Schedule: shift schedule: Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process. We could also mention that shift schedule may vary? Not given. We'll just put that. Now we need to ensure we don't create sections with filler like "commensurate with experience". Not present. Now produce HTML:

      About the role

      Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Role Overview: The QC Specialist, Lab Services, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/She will serve as technical specialist within job function. Thinks logically and acts decisiously. This position will be located in Raritan, NJ and may require up to 5% of travel. This position will occasionally require to lift up to 20 pounds.

      Note: I corrected "acts decisively". Also ensure no extra spaces. Then

      Responsibilities

      • Prepares and reviews documentation independently.
      • Responsible for QC sample and retain management.
      • Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
      • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS).
      • Prepare documents and coordinate Sample shipment (internal and external shipments).
      • Review logbooks and/or LIMS to align physical quantities of samples in freezers/refrigerators.
      • Periodic inspection and consolidation of retains.
      • Document and perform sample management related non-conformance investigations.
      • Document and handle corrective and preventative action records.
      • Supports internal and regulatory audits.
      Then

      Requirements

      • A minimum of a Bachelor’s degree or higher.
      • A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry.
      • A degree in Biology, Biochemistry, Microbiology, Chemistry or related field.
      • Solid understanding of regulatory requirements, policies and guidelines.
      • Experience with Quality Control document reviews and regulatory inspection processes.
      • Working knowledge of Quality systems.
      • Experience in management of retain samples

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