Chemist, Quality Control

Date

06/2020

Location

1200 Airport Road, North Brunswick NJ 

Title

Chemist, Quality Control 1, 2 & 3

Department

Quality Control

Reports to

Manager, Analytical, R&D, & Method Validation

FLSA (Exempt or Non-Exempt

Non- Exempt

Role Overview

The Chemist, QC role is responsible for performing analytical testing, laboratory investigations, data review, and quality control activities to ensure the identity, strength, purity, and quality of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples. The role operates within an FDA-regulated laboratory environment and supports compliance with cGMP, Good Documentation Practices, company procedures, and applicable regulatory requirements.

The Chemist performs chemical and physical analysis using a variety of analytical techniques and laboratory instrumentation, including HPLC/UPLC, GC, ICP-MS, UV-Visible Spectrophotometer, FTIR, Auto Titrators, Dissolution Apparatus, Karl Fischer Titrators, Bulk Density Testing, Potentiometers, and other QC laboratory equipment. The role is responsible for accurate testing, documentation, instrument operation, troubleshooting, and communication of analytical results to support product quality and timely release.

Throughout all levels, the Chemist is expected to demonstrate strong analytical skills, attention to detail, problem-solving ability, and commitment to quality and compliance. The career progression moves from executing established laboratory procedures at the entry level to independently managing complex analytical challenges, supporting method validation/verification, compendial compliance, and providing technical leadership within the QC organization.

Areas of Responsibility

Chemist, QC 1: 

The Chemist, QC I is an entry-level laboratory professional responsible for performing routine chemical and physical analysis of raw materials, in-process samples, finished products, and stability samples according to established official and in-house test procedures. The Chemist evaluates samples for identity, strength, purity, and quality attributes while developing proficiency in analytical techniques, laboratory instrumentation, and GMP laboratory practices.

The Chemist, QC I works under the guidance of experienced chemists and supervisors to ensure testing is performed accurately, safely, and in compliance with company procedures, cGMP, and regulatory requirements.

 Key Responsibilities

• Perform routine sampling, chemical testing, physical testing, and assays of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples in an FDA-regulated laboratory environment.
• Perform analytical testing using wet chemistry techniques and laboratory instrumentation, including:
  • HPLC/UPLC
  • GC
  • IR/FTIR
  • UV-Visible Spectrophotometer
  • Auto Titrator
  • Dissolution Apparatus
  • Karl Fischer (KF)
  • Potentiometer
  • Bulk Density testing
• Prepare reagents, standards, solutions, and samples according to approved procedures.
• Perform assigned testing activities and accurately document analytical results.
• Support troubleshooting and testing of specific batches to assist with identification of potential causes of out-of-specification (OOS) results.
• Assist with customer complaint investigations by providing analytical test results.
• Prepare and review QC documentation, including test records, SOPs, test procedures, and protocols as assigned.
• Perform routine instrument maintenance and calibration activities under supervision and training.
• Maintain laboratory organization, housekeeping, safety, and chemical waste compliance.
• Follow cGMP, Good Documentation Practices, and company quality requirements.
• Complete approximately:
  • 95% analytical testing activities
  • 5% documentation and record review activities.
• Work extended hours or occasional weekends as required.
• Perform other duties as assigned.

Chemist, QC 2: 

The Chemist, QC II is an experienced laboratory professional responsible for performing routine and complex analytical testing with increased independence. This role applies technical knowledge to troubleshoot analytical issues, support investigations, review data, maintain laboratory equipment, and provide technical support to QC operations.

Chemist, QC II demonstrates proficiency with analytical instrumentation and applies knowledge of cGMP, and laboratory procedures to ensure accurate and timely testing.

Key Responsibilities

Includes all Chemist, QC I responsibilities, with increased ownership and accountability:

• Independently perform chemical, physical, and instrumental testing of raw materials, APIs, in-process materials, finished products, and stability samples.
• Perform complex analytical testing using QC instrumentation including:
  • HPLC/UPLC
  • GC
  • IR/FTIR
  • UV-Visible Spectrophotometer
  • Dissolution
  • Karl Fischer
  • Auto Titrator
  • Potentiometer
  • Other QC laboratory equipment.
• Troubleshoot analytical testing issues and instrument-related challenges.
• Support investigations related to:
  • Out-of-specification (OOS) results
  • Atypical results
  • Customer complaints
  • Product quality concerns
• Analyze test results and provide technical input to assist with root cause determination and corrective actions.
• Review analytical data and QC documentation for accuracy and completeness.
• Prepare and revise SOPs, test procedures, protocols, and laboratory documentation.
• Perform instrument maintenance, calibration, and troubleshooting activities with limited supervision.
• Support continuous improvement activities within the QC laboratory.
• Provide technical support and guidance to QC Chemist I personnel.
• Ensure compliance with customer specifications, company requirements, and federal, state, and local regulations.
• Maintain laboratory safety, compliance, and documentation standards.
• Work extended hours or weekends as needed.

Chemist, QC III :

The Chemist, QC III is a senior-level technical contributor responsible for both routine and advanced analytical testing, complex troubleshooting, laboratory investigations, and technical leadership within the QC organization. This role serves as a subject matter expert for analytical methods, instrumentation, and laboratory practices while supporting compliance, continuous improvement, and cross-functional initiatives.

Key Responsibilities

Includes all Chemist, QC II responsibilities, with increased technical leadership:

• Serve as a technical resource for analytical testing, instrumentation, and laboratory troubleshooting.
• Perform and oversee complex analytical testing activities for raw materials, APIs, in-process materials, finished products, and stability samples.
• Lead troubleshooting activities for specific batches and analytical issues to determine root cause and recommend corrective actions.
• Lead or support complex investigations related to:
  • OOS results
  • Deviations
  • Customer complaints
  • Product quality issues.
• Review and provide technical approval of analytical data and laboratory documentation.
• Support analytical method validation, verification, transfer, and optimization activities.
• Develop, review, and improve SOPs, test procedures, protocols, and technical reports.
• Provide technical guidance and mentoring to QC Chemist I and QC Chemist II team members.
• Support internal audits, customer audits, and regulatory inspections.
• Identify opportunities for laboratory process improvements and operational efficiency.
• Partner with Quality Assurance, Manufacturing, Research & Development, and other cross-functional teams.
• Maintain compliance with cGMP, FDA requirements, safety standards, and company procedures.
• Keep management informed of laboratory activities, risks, and improvement opportunities.

Other Responsibilities Including Safety:

Requirements

Education & Qualification:

Education

• Bachelor’s degree in chemistry or related scientific discipline required.
• One year of basic chemistry laboratory experience (academic experience acceptable) preferred.

Experience Progression

Chemist, QC I

• 0–2 years laboratory experience.
• Entry-level analytical laboratory experience preferred.

Chemist, QC II

• 2–5 years QC laboratory experience.
• Experience in dietary supplements, food, OTC, pharmaceutical, or regulated manufacturing preferred.

Chemist, QC III

• 5+ years progressive QC laboratory experience.
• Experience in dietary supplements, food, OTC, pharmaceutical, or regulated manufacturing preferred.
• Demonstrated technical expertise in analytical testing, troubleshooting, and investigations, validation/verification.

Certifications, Licenses, Credentials:

Skills & Abilities

Chemist, QC I

• Ability to follow procedures and accurately perform laboratory testing.
• Strong attention to detail and documentation skills.
• Ability to work effectively within a team environment.
• Basic knowledge of cGMP, and Good Documentation Practices.
• Basic Microsoft Word and Excel skills.

Chemist, QC II

• Ability to independently perform analytical testing and troubleshoot issues.
• Strong understanding of cGMP, and 21 CFR Part 11 requirements.
• Ability to prepare clear technical reports and documentation.
• Strong problem-solving and time-management skills.
• Ability to support continuous improvement activities.
• Experience with chromatography software preferred.

Chemist, QC III

• Advanced analytical troubleshooting skills.
• Strong technical writing and investigation skills.
• Ability to mentor and train laboratory personnel.
• Strong understanding of quality systems and regulatory expectations.
• Ability to lead technical projects and improvements.

Preferred Technical Experience

Experience with analytical instruments and software such as:

• Shimadzu LC2010
• Shimadzu Nexera
• GC2010
• Thermo ICP-MS
• LabSolutions
• Waters Empower Chromatography Software

Physical Requirements (lifting, etc.): 

Work Environment (Office, Warehouse, temperature extremes, etc.):