QC Chemist II & III

Job Title: Quality Control (QC) Chemist II

Location: Fall River, MA

Work Hours: 8:30 AM – 5:00 PM (may vary based on business needs)

Job Purpose:

The QC Chemist II is responsible for performing testing and analysis on various samples using specialized techniques and equipment in the Quality Control laboratory. This role involves conducting routine and advanced testing, ensuring compliance with GMP, and performing method validation/verification.

Key Responsibilities:

Preparation & Execution:

Prepare protocols for and execute analytical method validation, verification, and method transfer.

Conduct cleaning validation, including residue analysis.

Perform testing and analysis of raw materials, in-process materials, and finished products.

Testing & Instrumentation:

Utilize instruments such as HPLC, GC, Karl Fischer, ICP, Particle Size, etc., for analytical testing.

Lead and/or participate in investigation activities related to testing deviations or issues.

Compliance & Documentation:

Ensure all testing and documentation follow GMP and SOP guidelines, including data integrity and good documentation practices.

Maintain accurate records of testing results and adhere to all regulatory standards.

Team Support:

Support the Quality Control team and assist with departmental or cross-functional investigations.

Perform other duties as assigned by the department head or section lead.

Qualifications:

Education:

Bachelor's degree (BS/BA) in Chemistry or a related physical science field is preferred.

Experience:

Minimum 2 years of experience as a QC Chemist in a pharmaceutical manufacturing or R&D setting.

3+ years of in-lab chemist experience (must have).

Hands-on experience with analytical instruments such as HPLC, GC, Karl Fischer, ICP, and Particle Size analysis.

Experience with Inhalation products (MDI) is a plus.

Knowledge & Skills:

Strong understanding of cGMP, SOPs, Lab Safety, and USP requirements.

Proficiency in using Microsoft Office and other scientific software.

Must be proficient in English (both spoken and written) and able to communicate scientific concepts effectively.

Behavioral & Professional Expectations:

Must be able to work in a pharmaceutical manufacturing or packaging environment.

Must be willing to work various shifts (first or second shift) as required.

Ability to perform work with a high degree of accuracy, attention to detail, and adherence to regulations.

Must be flexible and able to work weekends based on business needs.

No remote work available.

Physical & Work Environment Requirements:

Ability to stand/walk for 75% or more of an 8-hour shift.

Ability to lift up to 10 kg unassisted.

Must be able to wear personal protective equipment (PPE) as required (e.g., lab coats, safety glasses, respiratory equipment).

Exposure to solvents, powders, and chemicals commonly used in pharmaceutical environments.

Ability to work in a cGMP lab or manufacturing environment.