Senior Chemist

About the role

We are seeking an experienced Quality Control Chemist to support analytical testing, method validation, laboratory investigations, and regulatory compliance within a pharmaceutical manufacturing environment. This role ensures the quality and release of raw materials, in-process materials, packaging components, and finished products while maintaining compliance with cGMP, GLP, and FDA requirements.

Responsibilities

• Perform analytical testing of raw materials, packaging materials, in-process samples, finished products, and utility systems.
• Develop and maintain specifications, test methods, SOPs, and laboratory documentation.
• Conduct method validations, transfers, and suitability studies.
• Investigate OOS/OOT results and support deviations, CAPAs, change controls, and quality risk assessments.
• Review analytical data and approve Certificates of Analysis (COAs).
• Manage laboratory equipment qualification, calibration, maintenance, and documentation.
• Support internal, customer, and regulatory audits while maintaining inspection readiness.
• Ensure compliance with data integrity, GMP, GLP, and laboratory best practices.

Requirements

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Microbiology, or a related scientific field.
• 5+ years of Quality Control experience in the pharmaceutical industry.
• Hands-on experience with GC, FTIR, TOC, UV-Vis, and other analytical instrumentation.
• Experience supporting sterile injectable manufacturing environments.
• Strong knowledge of cGMP, GLP, FDA regulations, USP, ICH guidelines, and data integrity requirements.

Qualifications

• Experience with method validation, equipment qualification (IQ/OQ/PQ), and laboratory investigations.
• Familiarity with LIMS and electronic laboratory systems.
• Excellent technical writing, problem-solving, and communication skills.

Pay

The pay range for this position is $40.87 - $55.29/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Schedule

The position operates within a GMP Clean Room environment with a standard shift from 8:30 am to 5 pm. Flexibility may be required if demands change.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)