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Key Responsibilities and Required Skills for a Quality Control Chemist

💰 $55,000 - $85,000

Quality ControlPharmaceuticalChemistryLaboratoryManufacturing

🎯 Role Definition

The Quality Control (QC) Chemist is a cornerstone of our commitment to product integrity and patient safety. This role serves as a hands-on analytical expert within a regulated laboratory environment, primarily focused on conducting precise chemical and physical testing of raw materials, in-process samples, and finished products. By meticulously applying scientific principles and adhering to stringent cGMP (current Good Manufacturing Practices) and safety standards, the QC Chemist ensures that all products consistently meet established quality, purity, and efficacy specifications before they reach the market. This position is critical for identifying deviations, supporting investigations, and maintaining the data integrity that underpins regulatory compliance and consumer trust.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Control Technician
  • Associate Chemist
  • Recent Graduate (Chemistry, Biochemistry)

Advancement To:

  • Senior QC Chemist / QC Chemist II/III
  • Quality Control Supervisor or Team Lead
  • Quality Control Manager

Lateral Moves:

  • Method Development & Validation Scientist
  • Quality Assurance Specialist
  • R&D Chemist

Core Responsibilities

Primary Functions

  • Execute a wide range of complex analytical tests on raw materials, packaging components, in-process materials, and finished goods according to established SOPs and compendial methods (e.g., USP, EP).
  • Operate, maintain, and troubleshoot sophisticated analytical instrumentation, including but not limited to HPLC, GC, FTIR, UV-Vis Spectrophotometers, and dissolution apparatus.
  • Perform routine calibration and performance verification of laboratory equipment to ensure instruments are operating within specified parameters and producing reliable data.
  • Meticulously document all testing activities, observations, and results in laboratory notebooks and electronic systems (LIMS) in strict adherence to Good Documentation Practices (GDP).
  • Analyze and interpret analytical data, comparing results against pre-defined specifications to determine if materials and products meet quality standards.
  • Conduct peer review of analytical data and documentation generated by other chemists to ensure accuracy, completeness, and compliance with procedures.
  • Initiate and actively participate in laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and other aberrant results, working to identify root causes.
  • Prepare and standardize volumetric solutions, reagents, and mobile phases needed for analytical procedures, ensuring their quality and suitability for use.
  • Manage the laboratory's chemical inventory, including the safe handling, storage, and disposal of hazardous materials in compliance with EHS regulations.
  • Perform stability testing on finished products according to established protocols to support product shelf-life dating and storage conditions.
  • Assist in the qualification of new laboratory instruments and equipment, executing IQ/OQ/PQ protocols as required.
  • Validate and/or transfer new analytical test methods from R&D or other sites into the QC laboratory, ensuring the methods are robust and suitable for routine use.
  • Generate and formally report analytical testing results through Certificates of Analysis (CofA) and other required documentation for batch release.
  • Author, review, and revise Standard Operating Procedures (SOPs), test methods, and other controlled documents to reflect current practices and regulatory requirements.
  • Maintain a clean, organized, and safe laboratory workspace, consistently following all environmental health and safety (EHS) guidelines.
  • Collect and test purified water and environmental monitoring samples to ensure the manufacturing environment is maintained in a state of control.
  • Prepare clear and concise technical reports summarizing investigation findings, method validation data, or other complex scientific activities.
  • Provide analytical support for process validation and cleaning validation activities by testing relevant samples in a timely manner.
  • Interface with auditors from regulatory agencies (e.g., FDA) and customers by presenting and defending laboratory data and quality systems.
  • Proactively identify opportunities for continuous improvement within the laboratory, suggesting enhancements to testing efficiency, safety, or compliance.

Secondary Functions

  • Support internal and external audits by retrieving documentation, explaining laboratory procedures, and speaking to data integrity practices.
  • Participate in cross-functional teams to help troubleshoot manufacturing quality issues, providing analytical expertise and data-driven insights.
  • Assist in training junior chemists on laboratory procedures, instrumental techniques, software systems, and cGMP/safety compliance.
  • Contribute to the drafting and revision of key quality documents, such as Standard Operating Procedures (SOPs), test methods, and instrument work instructions.

Required Skills & Competencies

Hard Skills (Technical)

  • Chromatography (HPLC/GC): Deep proficiency in the operation, maintenance, and troubleshooting of HPLC and GC systems, including experience with data platforms like Empower or Chromeleon.
  • Spectroscopy Techniques: Hands-on experience with various spectroscopic methods such as UV-Vis, FTIR, and Atomic Absorption (AA) for material identification and quantification.
  • Wet Chemistry: Competence in classical chemistry techniques including titrations, gravimetric analysis, and physical testing (e.g., pH, viscosity, density).
  • cGMP & Regulatory Compliance: Thorough understanding and practical application of cGMP/GLP regulations, FDA guidelines, and compendial standards (USP/EP/JP).
  • Method Validation/Verification: Knowledge of the principles and execution of analytical method validation, verification, and transfer per ICH guidelines.
  • Laboratory Information Management Systems (LIMS): Experience using LIMS for sample tracking, data entry, and results reporting in a regulated setting.
  • Technical Writing: Ability to write, review, and revise clear and compliant technical documents, including SOPs, test methods, and investigation reports.
  • Data Integrity Principles: Strong grasp of ALCOA+ principles and the importance of maintaining data integrity throughout the entire data lifecycle.

Soft Skills

  • Meticulous Attention to Detail: Essential for accurate execution of complex procedures, precise data recording, and identifying subtle deviations that could impact product quality.
  • Problem-Solving & Critical Thinking: The ability to systematically troubleshoot instrument issues and investigate anomalous results to determine the scientific root cause.
  • Time Management & Organization: Proven capacity to manage multiple testing priorities, meet tight deadlines for batch release, and maintain an organized workflow in a fast-paced environment.
  • Effective Communication: Clear and concise written and verbal communication skills are necessary for collaborating with team members, documenting findings, and interacting with other departments.
  • Teamwork & Collaboration: A cooperative mindset to work effectively with fellow chemists, supervisors, and cross-functional partners in QA and Manufacturing.
  • Adaptability: Flexibility to respond to shifting priorities, unexpected results, and evolving regulatory expectations without compromising quality.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor of Science (B.S.) degree from an accredited university or college.

Preferred Education:

  • Master of Science (M.S.) degree.

Relevant Fields of Study:

  • Chemistry (Analytical, Organic, or General)
  • Biochemistry
  • Pharmaceutical Sciences
  • Related physical science field

Experience Requirements

Typical Experience Range:

  • 2-5 years of direct, hands-on experience working in a Quality Control laboratory within a cGMP regulated environment.

Preferred:

  • Experience in the pharmaceutical, biotechnology, or medical device industry is highly desirable. Direct experience with method validation, stability programs, and participating in regulatory inspections is a significant plus.
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