Job Description

Job Title: Quality Control (QC) Chemist II – Method Validation

Industry: Pharmaceutical Manufacturing

Location: Fall River, MA

Job Type: Full-Time | On-site

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

Reports To: QC Manager

Required Citizenship / Work Permit / Visa Status:

• US Citizen/Green Card Holder/TN Visa/H1B Transfers/OPT-EAD

About the Role

We are seeking an experienced Quality Control (QC) Chemist II to join our QC team in Fall River, MA. The QC Chemist will perform testing of samples using advanced analytical methods and specialized laboratory instruments to ensure compliance with cGMP, data integrity, and regulatory guidelines. This role focuses heavily on method validation, method verification, and method transfer within a fast-paced pharmaceutical environment.

Key Responsibilities

• Prepare and execute analytical method validation, verification, and transfer protocols .
• Perform cleaning validation (residue analysis) and raw material testing/release.
• Conduct advanced and routine laboratory testing using instruments such as HPLC, GC, ICP, Karl Fischer, Particle Size Analyzer , and more.
• Ensure strict adherence to cGMP, GLP, and good documentation practices .
• Lead investigation activities and participate in compliance audits as required.
• Maintain accurate lab records and support continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure project deadlines and quality standards are met.

Education & Experience

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or related physical sciences required.
• Minimum 2 years of recent QC Chemist experience in a pharmaceutical company (generic pharma preferred).
• Strong hands-on expertise with analytical method validation, verification, and transfer .
• Must have small molecule experience .
• Proficiency in cGMP, SOP compliance, and data integrity .
• Experience with inhalation products (MDI) is a strong plus.
• Excellent English communication skills (reading, writing, and technical discussions).

Working Conditions

• On-site role in a cGMP laboratory .
• Requires use of PPE (lab coat, safety glasses, gloves, etc.).
• May involve working with solvents, powders, or pharmaceutical raw materials.
• Some evening, weekend, or holiday work may be required.
• No remote work available.

Physical Requirements

• Standing/walking unassisted for up to 75% of an 8-hour shift.
• Lifting up to 10 kg when required.
• Ability to work at a computer or laboratory bench for extended periods.

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