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Key Responsibilities and Required Skills for Lab Quality Control Inspector

💰 $50,000 - $75,000

Quality ControlLaboratoryInspection

🎯 Role Definition

The Lab Quality Control Inspector performs systematic inspections, sampling, analytical testing support, and documentation review to ensure raw materials, in‑process samples, and finished products meet established quality standards and regulatory requirements. This role enforces SOPs, maintains data integrity, supports laboratory operations (HPLC/GC/microbiology/chemical assays), investigates deviations, and works cross-functionally with production and QA to release product and drive continuous improvement.

📈 Career Progression

Typical Career Path

Entry Point From:

  • QC Lab Assistant / QC Technician
  • Production Operator with sampling responsibilities
  • Laboratory Intern or Medical Laboratory Technician

Advancement To:

  • Senior QC Inspector / Lead QC Analyst
  • QC Supervisor / Quality Assurance Specialist
  • Quality Control Manager or Validation Engineer

Lateral Moves:

  • Analytical Chemist
  • Regulatory Affairs Associate
  • Manufacturing Process Technician

Core Responsibilities

Primary Functions

  • Conduct structured incoming inspection of raw materials, components, and packaging using defined criteria and sampling plans; document findings in LIMS and generate non-conformance reports when specifications are not met.
  • Perform routine and investigational analytical testing (e.g., HPLC, GC, UV-Vis, wet chemistry, pH, titration) following established SOPs, lab safety guidelines, and method validation parameters to support disposition decisions.
  • Execute microbiological quality control tests, including environmental monitoring, bioburden testing, sterility assays, and contaminant identification using aseptic technique and culture-based methods where applicable.
  • Collect in-process and finished product samples according to sampling plans and chain of custody procedures; prepare and label samples to preserve integrity and ensure traceability throughout testing.
  • Verify test results and instrument outputs against acceptance criteria; escalate out-of-specification (OOS) results immediately to Quality Assurance and participate in preliminary investigations.
  • Maintain and calibrate laboratory instruments and equipment (e.g., balances, pipettes, spectrophotometers, chromatography systems) and record calibration and maintenance activities per preventive maintenance schedules.
  • Review batch records, analytical worksheets, and COAs for completeness, accuracy, and compliance with cGMP/GLP/ISO requirements; identify discrepancies and raise deviations or CAPAs as required.
  • Support stability testing programs by receiving, logging, and preparing stability samples, documenting environmental chamber conditions, and recording test outcomes in stability databases.
  • Perform first-article and release inspections of finished goods, including specification verification and labeling checks, prior to final release to distribution under QA oversight.
  • Lead root-cause analysis for non-conforming results using established problem-solving tools (5 Whys, Fishbone diagrams) and recommend corrective and preventive actions; monitor effectiveness of implemented CAPAs.
  • Execute environmental and contamination control monitoring (e.g., particulate counts, surface swabs) in controlled areas and gowning verification to ensure cleanroom and manufacturing area compliance.
  • Operate and administer Laboratory Information Management Systems (LIMS) to log sample information, testing activities, and generate standard reports to support traceability and audit readiness.
  • Prepare and maintain comprehensive QC documentation—including laboratory notebooks, bench records, deviation reports, test summaries, and trend analyses—ensuring data integrity and audit trail completeness.
  • Participate in internal and external supplier and vendor audits; perform supplier quality checks and incoming supplier documentation reviews to support supplier qualification and management.
  • Support method development and transfer activities by executing verification runs, documenting limitations, and providing technical feedback to analytical development teams.
  • Coordinate with Production, Quality Assurance, and Engineering to triage manufacturing issues, prioritize testing activities, and implement containment plans for suspected quality events.
  • Train and mentor junior QC staff and laboratory technicians on testing procedures, SOP compliance, safety, and proper documentation practices to build bench competency and compliance.
  • Contribute to continuous improvement projects by analyzing quality metrics, performing trending analysis, and proposing process optimizations to reduce rework, scrap, and testing cycle-time.
  • Ensure adherence to regulatory requirements and company policies (FDA, EMA, ISO 9001, cGMP/GLP) in all QC activities and support regulatory inspections by providing requested documentation and explanations.
  • Manage inventory of QC reagents, media, and critical supplies; perform lot verification and shelf life checks and coordinate replenishment to maintain uninterrupted testing capabilities.
  • Verify and implement labeling, packaging, and documentation changes associated with product updates or corrective actions, ensuring updated documents are used in testing and release.
  • Handle hazardous and controlled materials safely, follow waste disposal policies, and ensure laboratory safety protocols (PPE, SDS management, spill response) are enforced at the bench level.
  • Generate and present periodic QC performance reports (e.g., OOS trends, CAPA status, test throughput) to QA management and cross-functional stakeholders to inform decision-making.
  • Support electronic record systems and ensure compliance with data integrity principles (ALCOA+): accuracy, legibility, contemporaneousness, original records, and attributable actions.

Secondary Functions

  • Assist with development and revision of SOPs, test methods, and work instructions to reflect current best practices and regulatory expectations.
  • Support cross-functional investigations and root cause teams for manufacturing deviations, customer complaints, and product recalls as needed.
  • Participate in periodic laboratory audits and inspection readiness activities; help implement corrective actions from internal and external audit findings.
  • Facilitate supplier quality investigations and vendor corrective actions when raw material discrepancies or out-of-spec trends are identified.
  • Provide subject-matter input for equipment qualification (IQ/OQ/PQ) and validation projects, ensuring QC requirements are incorporated.
  • Create and maintain bench-level training materials, competency matrices, and refresher training plans for QC personnel.
  • Assist in data queries and electronic batch record reviews during system upgrades or migrations to maintain continuity of lab operations.
  • Support ad-hoc testing requests during product development or scale-up activities and collaborate with R&D to transfer validated methods into routine QC operations.

Required Skills & Competencies

Hard Skills (Technical)

  • Hands-on analytical testing skills: HPLC, GC, UV-Vis spectrophotometry, titration, pH measurement, and wet chemistry techniques.
  • Microbiology techniques: aseptic technique, plate counts, membrane filtration, sterility testing, and environmental monitoring.
  • Proficient use of Laboratory Information Management Systems (LIMS) and electronic laboratory notebooks (ELN) for sample tracking and documentation.
  • Strong understanding of cGMP, GLP, ISO 9001, and FDA regulatory expectations related to laboratory practices and product release.
  • Experience with method validation, method transfer, and verification protocols for analytical assays.
  • Instrument qualification and maintenance: IQ/OQ/PQ knowledge, calibration practices, and troubleshooting of bench-top and chromatography instruments.
  • Data integrity and good documentation practices (ALCOA+), including electronic records and audit trail management.
  • Knowledge of statistical tools and SPC (statistical process control) for trend analysis, capability studies, and control charts.
  • Proficiency with MS Office (Excel for data trending and pivot tables, Word for reports, PowerPoint for presentations).
  • Experience writing and managing deviations, CAPAs, non-conformance reports, and change control documentation.
  • Sample handling and chain-of-custody procedures, including cold chain and quarantine workflows.
  • Familiarity with safety protocols, SDS interpretation, hazardous waste handling, and controlled-substance procedures when applicable.

Soft Skills

  • Meticulous attention to detail and high degree of accuracy in test execution and documentation.
  • Strong analytical and problem-solving ability with experience conducting root cause analysis and implementing corrective actions.
  • Clear written and verbal communication skills for report writing, deviations, and cross-functional collaboration.
  • Time management and prioritization to manage multiple tests, deadlines, and urgent release requests.
  • Team player with the ability to mentor junior staff and collaborate across production, QA, and R&D teams.
  • Ethical decision-making and integrity when handling quality issues and reporting non-conformances.
  • Adaptability to changing priorities, new methods, and continuous improvement initiatives.
  • Critical thinking and the ability to interpret technical data and translate it into actionable recommendations.
  • Attention to data security and confidentiality, especially when handling proprietary or regulated information.
  • Customer service orientation to support internal stakeholders and external auditors with timely, professional responses.

Education & Experience

Educational Background

Minimum Education:

  • High School Diploma or GED with demonstrated laboratory experience; or
  • Associate Degree in Laboratory Science, Chemical Technology, Environmental Science, or related technical field.

Preferred Education:

  • Bachelor’s Degree in Chemistry, Biochemistry, Biology, Microbiology, Medical Laboratory Science, or a related scientific discipline.

Relevant Fields of Study:

  • Analytical Chemistry
  • Microbiology or Clinical Laboratory Science
  • Chemical Engineering Technology
  • Biotechnology

Experience Requirements

Typical Experience Range:

  • 1–5 years of hands‑on laboratory QC experience; experience in a regulated environment (pharmaceuticals, medical devices, food, or chemicals) is highly preferred.

Preferred:

  • 2–5+ years as a QC Analyst/Inspector with practical experience in GMP/GLP labs, proficiency in chromatographic and microbiological methods, and demonstrated involvement in investigations, CAPA, and audit support. Experience with LIMS and instrument qualification is strongly preferred.
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