Chemist

Quality Control Chemist

This position offers an experienced Quality Control Chemist the opportunity to support analytical testing, method validation, and regulatory compliance within a highly regulated pharmaceutical manufacturing environment. The chemist ensures the quality and timely release of raw materials, in-process materials, packaging components, and finished products while maintaining strict adherence to cGMP, GLP, FDA regulations, and data integrity requirements. The role contributes directly to product quality, patient safety, and continuous improvement initiatives across the laboratory and manufacturing operations.

Responsibilities

• Perform analytical testing of raw materials, packaging materials, in-process samples, finished products, and utility systems using appropriate validated methods.
• Develop, review, and maintain specifications, test methods, standard operating procedures (SOPs), and other laboratory documentation in compliance with regulatory and internal quality standards.
• Conduct method validations, method transfers, and method suitability studies to ensure robustness, accuracy, and reproducibility of analytical procedures.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results, identify root causes, and support the implementation of deviations, corrective and preventive actions (CAPAs), change controls, and quality risk assessments.
• Review analytical data for completeness, accuracy, and compliance, and approve Certificates of Analysis (COAs) for materials and finished products.
• Manage laboratory equipment qualification, calibration, maintenance, and associated documentation, including support for IQ/OQ/PQ activities where applicable.
• Ensure laboratory instruments such as HPLC, GC, FTIR, UV-Vis, and Karl Fischer titrators operate within validated parameters and remain in a state of control.
• Support internal, customer, and regulatory audits by providing documentation, explaining laboratory practices, and maintaining continuous inspection readiness.
• Ensure strict compliance with data integrity principles, cGMP, GLP, USP, ICH guidelines, FDA regulations, and laboratory best practices in all testing and documentation activities.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to support product release and resolve quality issues.
• Contribute to continuous improvement initiatives by identifying opportunities to enhance laboratory efficiency, method performance, and overall quality systems.
• Prepare clear, accurate technical documentation and reports related to analytical results, investigations, validations, and equipment qualifications.

Essential Skills

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Microbiology, or a related scientific field.
• At least 5 years of Quality Control experience in the pharmaceutical industry.
• Experience supporting sterile injectable manufacturing environments.
• Hands-on experience operating and troubleshooting HPLC, GC, FTIR, UV-Vis, Karl Fisher, and other analytical instrumentation.
• Strong knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), FDA regulations, USP and ICH guidelines, and data integrity requirements.
• Proven ability to perform and interpret analytical testing on raw materials, in-process samples, packaging components, and finished products.
• Experience reviewing analytical data and approving Certificates of Analysis (COAs) in a regulated environment.
• Demonstrated capability to investigate OOS/OOT results and support deviations, CAPAs, change controls, and quality risk assessments.
• Competence in managing laboratory equipment qualification, calibration, maintenance, and related documentation.
• Ability to maintain inspection readiness and support internal, customer, and regulatory audits.

Additional Skills & Qualifications

• Experience with method validation, including development and execution of validation protocols and reports.
• Experience with equipment qualification activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience in conducting laboratory investigations and documenting findings in a clear and compliant manner.
• Familiarity with Laboratory Information Management Systems (LIMS) and electronic laboratory systems.
• Strong technical writing skills for drafting SOPs, test methods, validation documents, and investigation reports.
• Effective problem-solving skills with the ability to identify root causes and propose practical corrective and preventive actions.
• Strong verbal and written communication skills for collaborating with cross-functional teams and presenting information during audits.
• Attention to detail and a quality-focused mindset suited to a highly regulated pharmaceutical environment.

Work Environment

The role is based in a GMP clean room environment within a pharmaceutical manufacturing facility, where the chemist works primarily in a Quality Control laboratory. The position…