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Key Responsibilities and Required Skills for Quality Control Lab Technician

💰 $45,000 - $65,000

Quality AssuranceLaboratoryPharmaceuticalsBiotechnology

🎯 Role Definition

A Quality Control (QC) Lab Technician performs routine and specialized analytical testing on raw materials, in-process samples and finished products to ensure safety, potency, purity and compliance with regulatory standards (cGMP/GLP/ISO 17025). The QC Lab Technician operates laboratory instrumentation (HPLC, GC, UV/VIS, FTIR), follows and develops Standard Operating Procedures (SOPs), documents test results in LIMS, supports investigations and CAPA, and partners with production and quality teams to enable timely lot release.

Primary keywords: Quality Control Lab Technician, QC analyst, analytical testing, HPLC, GC, microbiology, cGMP, LIMS, SOPs, method validation.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Laboratory Assistant / Lab Technician I
  • Production Technician with lab experience
  • Recent graduate with B.S. in Chemistry, Biology or related field

Advancement To:

  • Senior QC Analyst / Senior Lab Technician
  • QC Supervisor / Team Lead
  • Quality Assurance Specialist or Validation Engineer
  • QC Manager / Laboratory Manager

Lateral Moves:

  • Quality Assurance (QA) Specialist
  • Manufacturing/Process Development Technician
  • Analytical Development (R&D) Technician

Core Responsibilities

Primary Functions

  1. Perform routine and non-routine analytical testing of raw materials, in-process samples and finished products using HPLC, GC, UV/VIS, FTIR, titration and wet chemistry techniques, ensuring results meet product specifications and regulatory requirements.
  2. Prepare samples, reagents and standards according to detailed SOPs and test methods, maintaining traceability and reagent logs to comply with cGMP documentation practices.
  3. Operate, calibrate and perform daily instrument checks and preventative maintenance on analytical equipment (HPLC pumps, autosamplers, GC columns, balances, pH meters) and document status in calibration records.
  4. Accurately record all test data, observations and calculations in laboratory notebooks, electronic lab notebooks (ELN) or LIMS, ensuring data integrity, legibility and audit readiness.
  5. Review raw data, calculate results, flag out-of-specification (OOS) and out-of-trend results, and generate clear, reproducible test reports for review by senior staff and QA.
  6. Execute environmental and microbiological monitoring programs including plate counts, membrane filtration, sterility testing and endotoxin assays as applicable to the facility.
  7. Perform method qualification and validation support activities, following validation protocols and contributing to data collection, trending and summary reports.
  8. Investigate deviations, OOS events and laboratory incidents by collecting facts, preserving data, drafting investigation summaries and supporting CAPA implementation with cross-functional teams.
  9. Maintain strict adherence to Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and site-specific SOPs to ensure regulatory compliance and product quality.
  10. Participate in internal and external audits by preparing requested documentation, providing process descriptions and addressing auditor questions in collaboration with QA.
  11. Execute stability sample testing and data logging according to stability study protocols, tracking sample lifecycle and contributing to shelf-life determinations.
  12. Triage and prioritize testing workloads to meet production release timelines, communicating status and potential delays proactively to production and quality stakeholders.
  13. Dispose of chemical and biological waste in accordance with safety procedures and regulatory requirements, maintaining chemical inventory and SDS documentation.
  14. Assist in the development and revision of SOPs, test methods and work instructions by providing practical input based on day-to-day laboratory operations.
  15. Train new hires and junior technicians on lab procedures, instrument operation, safety practices and documentation expectations, and evaluate competency through observed practical exercises.
  16. Support root cause analysis for recurring test failures and implement corrective actions, including process adjustments, retraining and equipment changes.
  17. Conduct stability chamber audits and perform temperature mapping or monitoring activities to support controlled environment requirements.
  18. Collaborate with production, R&D and supply chain teams to resolve quality issues, support product investigations and provide technical guidance on analytical results.
  19. Manage laboratory supplies and consumables inventory, place orders, and ensure critical items are stocked to prevent testing interruptions.
  20. Ensure laboratory cleanliness, organization and compliance with 5S/lean principles, maintaining a safe working environment and ensuring all safety equipment is functional.
  21. Create and maintain accurate batch release documentation, certificates of analysis (CoA), and contribute to lot disposition recommendations in partnership with QA.
  22. Participate in continuous improvement initiatives to optimize workflows, reduce testing cycle time and improve data quality through automation or process change.
  23. Handle specialized testing such as dissolution, particle size analysis, moisture content (Karl Fischer), and assay by titration as required by product lines.
  24. Communicate effectively with cross-functional teams, escalate critical quality issues promptly, and support customer complaint investigations when analytical evidence is required.

Secondary Functions

  • Support continuous improvement activities in the lab: implement lean tools, suggest workflow changes and participate in root cause problem solving.
  • Maintain and update Laboratory Information Management System (LIMS) entries; assist with LIMS data integrity checks and report generation.
  • Provide ad-hoc analytical support for R&D projects, pilot runs and process troubleshooting as requested by development teams.
  • Assist QA in preparing quality metrics and KPIs (turnaround time, OOS rate, throughput) and recommend process improvements to meet targets.
  • Support equipment qualification (IQ/OQ/PQ) and assist engineering/validation teams with protocol execution and documentation.
  • Participate in cross-training initiatives to ensure bench coverage and flexibility across analytical methods and shifts.
  • Help manage supplier and vendor relationships for lab equipment service, calibration and consumable procurement.
  • Contribute to safety and compliance training sessions and help update laboratory safety documentation and chemical hygiene plans.

Required Skills & Competencies

Hard Skills (Technical)

  • Proficient operation and troubleshooting of analytical instruments: HPLC (analytical and preparative), GC, UV/VIS spectrophotometers, FTIR, and autosamplers.
  • Hands-on experience with wet chemistry techniques: titration, pH measurement, gravimetric and volumetric analysis.
  • Microbiology testing skills (when applicable): aseptic technique, plate counts, membrane filtration, sterility testing and incubation monitoring.
  • Experience with LIMS, ELN, or other laboratory data systems for sample management, test results entry and report generation.
  • Strong understanding of cGMP, GLP, ISO 17025 requirements and ability to follow and write compliant SOPs and batch records.
  • Proficient in method validation/qualification protocols and documentation (accuracy, precision, linearity, specificity, robustness).
  • Competent with laboratory equipment calibration, maintenance logs, preventative maintenance scheduling and IQ/OQ/PQ documentation.
  • Knowledge of data integrity principles (ALCOA+) and best practices for electronic and paper data management.
  • Experience with QA/QC documentation: Certificates of Analysis (CoA), lab notebooks, deviation reports, CAPA and change control systems.
  • Ability to perform statistical analysis and trend evaluation using Excel or statistical software (basic stats, control charts, regression).
  • Familiarity with safety and hazardous waste handling procedures, chemical inventory management and SDS compliance.
  • Experience executing environmental monitoring and stability testing programs.
  • Optional/Preferred: experience with particle size analysis, Karl Fischer titration, dissolution testing, and endotoxin testing (LAL).

Soft Skills

  • Strong attention to detail and high level of accuracy in sample preparation, data entry and result calculation.
  • Excellent documentation and technical writing skills to produce clear SOPs, reports and deviation narratives.
  • Analytical thinking and problem-solving skills for root cause investigations and corrective action implementation.
  • Effective verbal and written communication to interact with cross-functional teams, auditors and vendors.
  • Time management and prioritization skills to meet production release timelines and QC throughput targets.
  • Team player with the ability to train others, share knowledge and contribute positively to lab culture.
  • Adaptability and willingness to learn new methods, technologies and regulatory updates.
  • Strong ethical standards and commitment to data integrity and product quality.
  • Initiative and continuous improvement mindset to optimize lab processes and reduce waste.

Education & Experience

Educational Background

Minimum Education:

  • Associate degree in Chemistry, Biology, Biotechnology, or related laboratory discipline, or equivalent lab experience (1–3 years).

Preferred Education:

  • Bachelor of Science (B.S.) in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences or a related field.

Relevant Fields of Study:

  • Analytical Chemistry
  • Microbiology / Molecular Biology
  • Pharmaceutical Sciences
  • Biochemistry
  • Chemical Engineering (laboratory focus)

Experience Requirements

Typical Experience Range: 1–5 years in a regulated laboratory environment (pharmaceutical, biotech, food, cosmetics or chemical manufacturing).

Preferred:

  • 2–5+ years of hands-on QC laboratory experience with analytical instrumentation (HPLC/GC) and demonstrated GMP/GLP compliance.
  • Prior experience with LIMS and electronic data capture systems, and participation in audits or regulatory inspections.
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