Job Title: Stability Testing QC Chemist II
Location: Fall River, MA (On-site daily)
Employment Type: Full-Time
Work Hours: 8:00 AM – 5:00 PM (May vary depending on business needs)
Required Experience: 3+ Years
Industry: Pharmaceutical
Job Summary:
A pharmaceutical manufacturing organization is seeking a QC Chemist II – Stability Testing to support Quality Control operations. This position focuses on drug product quality assessments impacted by environmental factors, with an emphasis on analytical testing and regulatory compliance.
Key Responsibilities:
Conduct routine and advanced analytical testing on stability samples in accordance with established protocols.
Operate and maintain laboratory instruments such as HPLC, GC, Karl Fisher, ICP, and particle size analyzers.
Ensure testing is performed under cGMP and data integrity requirements.
Execute tests involving formulation stability and inhalation products (MDI).
Lead or participate in laboratory investigations and deviation reports.
Maintain accurate and complete documentation following Good Documentation Practices (GDP).
Support raw material testing and product release as needed.
Participate in continuous improvement initiatives and training activities.
Collaborate with cross-functional teams and support regulatory audits or inspections.
Perform other tasks as assigned by department leadership.
Required Qualifications:
Bachelor’s degree in Chemistry or a related physical science field.
Minimum 3 years of experience in formulation stability testing within the pharmaceutical industry.
Hands-on experience with analytical techniques including HPLC, GC, KF, ICP, and particle size analysis.
Experience with MDI (Metered Dose Inhalers) or inhalation product testing is highly preferred.
Strong understanding of cGMP, GDP, and regulatory expectations.
Proficient in scientific documentation and Microsoft Office applications.
Must be authorized to work permanently in the U.S. (US Citizen or Green Card holder).
Excellent analytical, organizational, and problem-solving skills.
Must be able to work on-site daily and handle physical requirements including standing/walking for extended periods and lifting up to 10 kg.
Benefits:
Day 1 Medical, Dental, Vision insurance
Disability Insurance
401(k) with Company Match
Bi-weekly pay and Paid Time Off
Shift differential and Overtime eligibility
Company-sponsored events and training programs
Career growth opportunities within a global organization
Working Conditions:
Laboratory and manufacturing environment requiring the use of PPE (e.g., lab coats, gloves, safety glasses).
May work around solvents, powders, or other pharmaceutical materials.
Must be able to sit at a desk or work at a computer for extended periods.