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Key Responsibilities and Required Skills for QC Lab Technician

💰 $45,000 - $65,000

ScienceQuality ControlLaboratoryManufacturingPharmaceuticalsFood & Beverage

🎯 Role Definition

Are you passionate about science and quality? This role requires a dedicated QC Lab Technician to be a cornerstone of our Quality Control department. This position is critical to our success, ensuring that every product leaving our facility is safe, effective, and meets all regulatory and internal specifications. You will apply your scientific skills in a fast-paced, regulated environment, directly impacting product integrity and consumer trust. The ideal candidate is a detail-oriented problem-solver with hands-on laboratory experience and a strong understanding of cGMP/GLP principles.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Recent graduate with a B.S. in a scientific field
  • Associate Lab Technician or Lab Assistant
  • Manufacturing or Production Operator with a quality focus

Advancement To:

  • Senior QC Lab Technician / QC Analyst II/III
  • QC Chemist or Microbiologist
  • QC Laboratory Supervisor or Team Lead

Lateral Moves:

  • Quality Assurance (QA) Specialist
  • Research and Development (R&D) Technician
  • Technical Writer or Document Control Specialist

Core Responsibilities

Primary Functions

  • Perform a wide range of analytical tests on raw materials, in-process goods, and finished products using established SOPs and test methods.
  • Operate, calibrate, and maintain sophisticated laboratory instrumentation such as HPLC, GC, FTIR, UV-Vis spectrophotometers, and dissolution apparatus.
  • Conduct wet chemistry techniques including titrations, pH measurements, viscosity, density, and loss on drying (LOD) with high precision.
  • Meticulously document all testing activities, observations, and results in laboratory notebooks and Laboratory Information Management Systems (LIMS) in compliance with cGMP/GLP.
  • Investigate and document Out-of-Specification (OOS), Out-of-Trend (OOT), and other aberrant laboratory results in collaboration with senior staff and management.
  • Prepare, standardize, and document chemical solutions, reagents, and reference standards required for analytical testing.
  • Adhere strictly to all laboratory safety protocols (EHS), company policies, and regulatory requirements, maintaining a clean and safe work environment.
  • Review and verify laboratory data generated by peers to ensure accuracy, completeness, and compliance with data integrity principles.
  • Perform environmental monitoring, including water sampling/testing and collecting surface and air samples in controlled manufacturing areas.
  • Execute stability testing protocols by pulling samples from stability chambers and performing required analyses according to the established schedule.
  • Collect and manage samples from production and warehouse areas, ensuring proper labeling, handling, and chain of custody.
  • Assist in the authoring, review, and revision of Standard Operating Procedures (SOPs), test methods, and other controlled quality documents.
  • Support method transfer and validation activities by executing protocols and documenting results as new products and methods are introduced.
  • Maintain and manage laboratory inventory, including ordering chemicals, consumables, and other necessary supplies to ensure uninterrupted lab operations.
  • Troubleshoot minor instrument issues and perform routine preventative maintenance to ensure equipment is in optimal working condition.
  • Participate actively in internal, client, and regulatory audits by providing data, documentation, and explanations for laboratory procedures.
  • Perform physical and sensory evaluations of materials and products as required by specifications.
  • Ensure proper disposal of chemical waste and expired materials according to established environmental and safety procedures.
  • Train junior technicians on laboratory procedures, equipment operation, and safety protocols as directed by laboratory management.
  • Compile and analyze test data to identify trends, prepare summary reports, and present findings to the quality team.
  • Support the qualification of new laboratory equipment and instrumentation by executing IQ/OQ/PQ protocols.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis for quality investigations.
  • Contribute to continuous improvement initiatives within the laboratory, such as refining test methods or improving workflow efficiency.
  • Collaborate with cross-functional teams, including Production, R&D, and Quality Assurance, to resolve quality-related issues and support new product introductions.
  • Participate in team meetings to discuss testing schedules, priorities, and laboratory challenges.

Required Skills & Competencies

Hard Skills (Technical)

  • Proficiency with analytical instrumentation (HPLC, GC, UV-Vis, FTIR).
  • Strong knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Experience with wet chemistry techniques (e.g., titration, pH, Karl Fischer).
  • Competency with Laboratory Information Management Systems (LIMS) and Chromeleon/Empower software.
  • Ability to perform accurate mathematical and statistical calculations.
  • Experience in writing, reviewing, and following Standard Operating Procedures (SOPs).
  • Understanding of USP, EP, and other relevant pharmacopeias.
  • Instrument calibration and basic troubleshooting skills.
  • Knowledge of data integrity principles (ALCOA+).
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Soft Skills

  • Exceptional attention to detail and organizational skills.
  • Strong analytical and problem-solving abilities.
  • Excellent written and verbal communication skills.
  • Ability to work effectively both independently and as part of a team.
  • Strong time management skills with the ability to manage multiple priorities in a fast-paced environment.
  • High level of integrity and a strong work ethic.
  • Adaptability and willingness to learn new techniques and processes.
  • Proactive and collaborative mindset.

Education & Experience

Educational Background

Minimum Education:

  • Associate's Degree in a scientific discipline with relevant lab experience.

Preferred Education:

  • Bachelor of Science (B.S.) Degree.

Relevant Fields of Study:

  • Chemistry
  • Biology
  • Biochemistry
  • Microbiology
  • Pharmaceutical Sciences

Experience Requirements

Typical Experience Range: 1-3 years of hands-on experience in a regulated QC laboratory environment (e.g., pharmaceutical, medical device, food, or cosmetics).

Preferred:

  • Direct experience in a cGMP-compliant manufacturing or laboratory setting.
  • Hands-on experience with chromatographic techniques, particularly HPLC.
  • Experience participating in laboratory investigations (OOS/OOT).
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