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Key Responsibilities and Required Skills for QC Analyst

💰 $45,000 - $80,000

Quality ControlLaboratoryPharmaceuticalManufacturing

🎯 Role Definition

The QC Analyst is responsible for performing laboratory testing and analytical duties that ensure product quality, regulatory compliance, and timely release of materials. This role executes validated analytical methods (HPLC, GC, UV-Vis, wet chemistry and microbiology), maintains accurate laboratory documentation in accordance with GMP/GLP/data integrity standards, participates in investigations and CAPA activities, and supports continuous improvement of quality systems. The ideal candidate is detail-oriented, scientifically rigorous, and skilled at translating lab results into clear, actionable quality decisions.

📈 Career Progression

Typical Career Path

Entry Point From:

  • QC Technician / Laboratory Technician with hands-on analytical experience
  • Recent graduates with a Bachelor's in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences
  • Production Support or Manufacturing Associate with testing exposure

Advancement To:

  • Senior QC Analyst / Lead QC Analyst
  • QC Supervisor / QC Team Lead
  • Quality Assurance Specialist or Manager
  • Analytical Scientist or Method Development Scientist

Lateral Moves:

  • Validation Specialist (analytical or equipment validation)
  • Regulatory Affairs Associate
  • Manufacturing Process Development or Technical Support

Core Responsibilities

Primary Functions

  • Execute routine and non-routine analytical testing of raw materials, in-process samples, bulk intermediates and finished products using validated methods such as HPLC, GC, ICP-OES, FTIR, UV-Vis spectroscopy and wet chemistry assays, ensuring results meet acceptance criteria and are documented in accordance with GMP.
  • Receive, log, and prioritize laboratory samples and associated paperwork into LIMS or paper batch records, ensuring chain of custody and traceability for every sample tested.
  • Prepare reagents, standards, calibration solutions and control samples following established SOPs, and maintain reagent stability logs and certificate of analysis tracking to support data integrity and method accuracy.
  • Review, interpret and trend analytical data, prepare formal test reports and Certificates of Analysis (CoA), and provide clear, justification-backed product release recommendations based on test results and specifications.
  • Perform method validation, method transfer and system suitability testing, including protocol execution, data analysis, reporting of validation results and generation of validation summary reports for regulatory readiness.
  • Investigate out-of-specification (OOS) and out-of-trend (OOT) results by executing scientific root-cause analysis, coordinating re-testing or alternate method testing, drafting investigation reports and recommending corrective and preventive actions (CAPAs).
  • Maintain, calibrate and perform routine preventative maintenance on laboratory instruments (HPLC, GC, balances, pH meters, incubators, environmental monitoring equipment) and qualify equipment according to the calibration and maintenance schedules.
  • Ensure full compliance with GMP/GLP, internal quality systems, SOPs and regulatory guidelines (FDA, EMA or local authorities), including adherence to ALCOA+/data integrity principles and electronic record controls.
  • Perform microbiological testing (aseptic technique, sterility testing, microbial limits, endotoxin assays) when applicable, and manage environmental monitoring programs including sampling, trend analysis and escalation of excursions.
  • Support stability testing programs by preparing, labeling and archiving stability samples, performing scheduled stability testing, tracking stability data and contributing to shelf-life and expiry documentation.
  • Create, review and revise analytical documentation: SOPs, work instructions, batch records, validation protocols, analytical reports and quality investigation documents to reflect current best practices and regulatory expectations.
  • Participate in internal and external regulatory audits and inspections by providing documentation, walk-throughs of lab activities, responses to auditor questions and implementing follow-up corrective actions.
  • Monitor and maintain laboratory safety and compliance programs by enforcing PPE requirements, chemical hygiene practices, inventory tracking of hazardous reagents and disposal of biohazardous waste in accordance with regulations.
  • Train and mentor junior analysts and new hires on laboratory techniques, SOPs, instrument operation, LIMS usage, and quality documentation practices, and evaluate competency through documented qualification exercises.
  • Support cross-functional product release activities, including interacting with production, QA, supply chain and R&D teams to expedite investigations, communicate quality status and enable timely product disposition.
  • Execute statistical analysis for assay precision, accuracy and stability trends using tools such as Excel or statistical software, and prepare data visualizations that support quality reviews and management decisions.
  • Participate in material lot disposition meetings by summarizing analytical findings, explaining risk assessments and recommending batch release, quarantine or rejection based on objective evidence.
  • Manage inventory and qualification of reference standards, control materials and critical consumables, ensuring lot traceability, storage conditions and stability verification are maintained and documented.
  • Drive continuous improvement initiatives in lab workflow, testing throughput and data quality by identifying bottlenecks, proposing root-cause solutions and supporting implementation of automation or LIMS enhancements.
  • Maintain thorough, audit-ready documentation for all laboratory activities, ensuring that notebooks, electronic records and review approvals are complete, legible, contemporaneous and compliant with data integrity requirements.
  • Coordinate with vendors and service providers for instrument service, reagent certification, and external testing needs while ensuring supplier documentation meets GMP/quality expectations.
  • Execute batch reconciliations, analytical sample disposition and disposal activities in alignment with quality and environmental health & safety policies, verifying proper approvals before material release or destruction.

Secondary Functions

  • Support cross-functional projects such as product transfers, scale-up activities and new product introductions by providing analytical input, method suitability assessments and quality risk evaluations.
  • Participate in cross-site or global quality initiatives to harmonize QC procedures, adopt best practices, and contribute to standardization of methods and SOPs across facilities.
  • Assist with LIMS administration tasks such as creating test methods, result templates, user permission reviews and troubleshooting routine system issues in collaboration with IT.
  • Create and maintain training matrices and competency records for the QC lab and escalate training gaps to management for remediation planning.
  • Help prepare material for regulatory submissions (CTD modules, stability summaries, analytical method descriptions) by providing accurate analytical data and method documentation.
  • Contribute to the organization’s continuous improvement and Lean initiatives by identifying waste, documenting process maps, performing root cause analysis and tracking improvements to completion.

Required Skills & Competencies

Hard Skills (Technical)

  • Proficient hands-on experience with HPLC (analytical and preparative), including column selection, mobile phase preparation, gradient method execution, system suitability and troubleshooting.
  • Practical experience with GC analysis (including headspace GC when applicable), MS interfacing, sample preparation techniques and peak identification.
  • Strong wet chemistry skills (titration, pH, conductivity, volumetric analysis) and ability to develop and perform classical assays.
  • Microbiological testing competency (aseptic technique, sterility testing, microbial limits, endotoxin/LAL assays) for biologics and aseptic products where applicable.
  • Familiarity with spectroscopy techniques (UV-Vis, IR/FTIR) and particle/bulk testing methodologies (particle size analysis, viscosity, specific gravity).
  • Working knowledge of analytical method validation, method transfer, system suitability criteria, accuracy/precision assessments and validation report writing.
  • Hands-on use and administration of Laboratory Information Management Systems (LIMS), and competence with electronic notebooks and electronic batch records.
  • Strong understanding of GMP, GLP, ISO standards and regulatory expectations (FDA, EMA) and practical experience applying those standards in a QC laboratory.
  • Data integrity and electronic records expertise, including ALCOA+ principles, audit trails, version control and secure data storage practices.
  • Proficiency in Microsoft Excel for data analysis (pivot tables, statistical summaries), basic statistical tools, and ability to generate clear charts and trend analyses.
  • Experience with instrument qualification, preventative maintenance scheduling, troubleshooting and coordinating third-party service interventions.
  • Familiarity with CAPA systems, deviation management, root cause analysis techniques (5 Whys, fishbone, FMEA) and corrective action tracking.

Soft Skills

  • Exceptional attention to detail and commitment to accuracy in testing, documentation and result interpretation.
  • Strong written and verbal communication skills for clear lab reports, deviation write-ups, SOP updates and cross-functional collaboration.
  • Critical thinking and methodical problem solving with the ability to prioritize tasks under tight timelines and escalate risks appropriately.
  • Team-oriented with demonstrated ability to train colleagues, work across functions and build productive working relationships.
  • Time management and organizational skills to balance routine testing, investigations and ad hoc requests while meeting deadlines.
  • Integrity and ethical judgment in handling data, following protocols and maintaining confidentiality of sensitive quality information.
  • Adaptability and continuous learning mindset to keep pace with new analytical technologies, regulatory changes and process improvements.
  • Customer-focused mindset to support internal stakeholders (Manufacturing, QA, R&D, Supply Chain) and external auditors or partners.
  • Resilience under pressure and the ability to remain calm, decisive and methodical during deviation investigations or inspection events.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Chemical Engineering or related STEM discipline.

Preferred Education:

  • Bachelor’s plus 2–4 years of QC laboratory experience, or a Master’s degree in a relevant scientific field.
  • Certifications or coursework in Good Manufacturing Practices (GMP), laboratory accreditation, or quality systems are advantageous.

Relevant Fields of Study:

  • Chemistry
  • Biochemistry
  • Microbiology
  • Pharmaceutical Sciences
  • Chemical Engineering

Experience Requirements

Typical Experience Range:

  • 1–5 years of hands-on laboratory experience in a regulated QC environment (pharmaceuticals, biotech, medical devices, food manufacturing).

Preferred:

  • 2–4+ years specifically performing analytical testing (HPLC/GC, wet chemistry, microbiology) in a GMP/GLP laboratory with documented experience in method validation, CAPA/OOS investigations, and LIMS usage.
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