Chemist, Quality Control

Reports to

Manager, Analytical, R&D, & Method Validation

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

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.

As described in the following sections (Chemist, QC 1, 2,
3).

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.

• 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.

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…