Quality Laboratory Chemist I/II

Schedule: Monday-Thursday evenings and Friday afternoon/evening.

Position Summary

The Quality Control Chemist will support laboratory operations through analytical testing activities in a regulated manufacturing environment. This individual will perform testing of products and materials, maintain compliance with established procedures, and contribute to continuous laboratory improvement efforts. The role requires strong organizational skills, attention to detail, and the ability to learn analytical techniques, instrumentation, and troubleshooting methods.

The ideal candidate will have prior experience working in an FDA-regulated, cGMP-compliant laboratory environment and be comfortable operating within established quality systems, documentation requirements, and regulatory expectations.

Key Responsibilities

Analytical Testing

• Perform routine and non-routine testing of raw materials, in-process samples, stability samples, and finished products according to approved procedures and industry standards.
• Execute analytical methods independently and accurately while maintaining compliance with quality and regulatory requirements.
• Document testing activities and results in accordance with laboratory procedures and good documentation practices.
• Review analytical data to ensure accuracy, completeness, and compliance with established specifications.
• Support investigations related to out-of-specification (OOS), out-of-trend (OOT), and atypical results as required.

Collaboration & Training

• Adapt to changing priorities and testing schedules while supporting team objectives.
• Assist in training laboratory personnel on testing procedures, instrumentation, and laboratory best practices.
• Work effectively with cross-functional groups including Quality Assurance, Manufacturing, Technical Operations, and Regulatory Affairs.
• Communicate testing status, laboratory issues, and project updates in a timely manner.

Safety & Compliance

• Maintain a strong commitment to workplace safety and quality.
• Follow all laboratory safety procedures, cGMP requirements, and applicable regulatory expectations.
• Ensure laboratory equipment is properly calibrated, maintained, and suitable for use.
• Adhere to data integrity principles and quality system requirements.

Laboratory Operations

• Operate and maintain analytical instrumentation, including chromatographic, spectroscopic, and wet chemistry systems.
• Support laboratory investigations, deviations, CAPAs, and change-control activities as needed.
• Assist with method implementation, laboratory process improvements, and continuous improvement initiatives.
• Stay informed of current regulatory expectations and industry standards relevant to quality control testing.
• Contribute to maintaining laboratory compliance with applicable quality systems and internal procedures.
• Complete laboratory projects and assignments within established timelines.

Preferred Technical Experience

Candidates should have hands-on experience with several of the following:

• High-Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• FTIR Spectroscopy
• UV/Visible Spectroscopy
• Dissolution Testing
• Wet Chemistry and Titration Techniques
• Analytical Balances and General Laboratory Equipment
• Chromatography data acquisition and processing systems

Highly Preferred

• Experience using Empower chromatography software for data acquisition, integration, review, reporting, and troubleshooting.
• Experience reviewing chromatographic data and maintaining data integrity within regulated laboratory environments.
• Familiarity with electronic laboratory documentation systems and audit-ready recordkeeping practices.

Regulatory & Quality Experience

The successful candidate will ideally have experience in:

• FDA-regulated laboratory environments.
• cGMP-compliant manufacturing and quality control operations.
• Pharmaceutical, biotechnology, consumer health, medical device, nutraceutical, or related regulated industries.
• Stability, release, and raw material testing programs.
• Laboratory investigations, including OOS and OOT assessments.
• Good Documentation Practices (GDP).
• Regulatory inspections and audit preparedness.
• Quality systems, deviations, CAPAs, and change control processes.

Physical Requirements

• Ability to stand and walk for extended periods throughout the workday.
• Ability to frequently bend, reach, squat, and use laboratory equipment.
• Ability to climb stairs as needed.
• Ability to lift, push, or pull materials and equipment up to approximately 50 pounds.
• Strong attention to detail and ability to perform basic mathematical calculations.

Qualifications

Chemist I

• Bachelor's degree in Chemistry or a related scientific discipline.
• Minimum of 2 years of analytical laboratory experience preferred.
• Experience working in an FDA-regulated and cGMP-compliant environment strongly preferred.

Chemist II

• Bachelor's degree in Chemistry or a related scientific discipline.
• 5-8 years of analytical laboratory experience in a regulated manufacturing environment.
• Demonstrated experience supporting quality control activities within FDA-regulated, cGMP-compliant laboratory operations.
• Experience independently executing analytical methods and supporting laboratory investigations.

Desired Skills

• Strong analytical and troubleshooting abilities.
• Excellent attention to detail and documentation practices.
• Ability to manage multiple priorities and meet deadlines.
• Effective verbal and written communication skills.
• Self-motivated with a collaborative, team-oriented approach.
• Working knowledge of FDA regulations, cGMP requirements, and quality systems.
• Commitment to quality, safety, compliance, and continuous improvement.
• Experience with Empower software is highly preferred.