Quality Control Chemist
Tedor Pharma Services, Cumberland, RI, United States
Quality Control Chemist
This position reports directly to the Quality Control Manager or Director and is responsible for managing and executing quality testing for drug substances in the commercial market, including method validation, release & stability testing for clinical trial and commercial drug products. The role ensures compliance with company policies, FDA regulations, and cGMP requirements, while maintaining accurate data review, analysis, and trending for raw materials, finished formulations, and stability samples.
Responsibilities
Lead collaboration between QC Analysts and Development Chemists, and cross‑department collaboration with drug product development, commercial operations, QA, and Analytical Development.
Evaluate QC laboratory operations and determine resources required to perform tests.
Generate, review, and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.).
Manage technical transfer of methods from internal labs for raw material analysis, in‑process testing, and API and drug product testing.
Review and report QC data, generate certificates of analysis, and monitor and trend data from internal and contract testing labs.
Initiate ICH stability study protocols and execute interim reports.
Manage and review out‑of‑specification or atypical result investigations, deviations, and CAPAs.
Investigate and troubleshoot method issues.
Review relevant sections of regulatory filings.
Monitor calibration schedules and maintain calibration data.
Contact vendors and schedule visits for PM/Calibration, repairs, and on‑site assistance.
Coordinate stability operations, determine sample requirements, develop stability protocols, and oversee execution.
Monitor stability chambers and chart recorders daily for environmental conditions and acceptance criteria.
Prepare stability data graphs, estimate expiration dates, and verify product shelf life.
Handle equipment qualification and data integrity programs.
Required Education & Experience
B.S. in Chemistry, Pharmaceutical Science, or related life‑science discipline.
5–7 years of laboratory experience in the pharmaceutical industry, QC.
3+ years of experience in a regulated manufacturing or QC laboratory performing analytical methods for pharmaceutical products.
Experience in QC testing of pharmaceutical and/or biologic products in a GMP environment.
Strong understanding of GMP compliance, CMC requirements for ANDAs, and regulatory filings.
Excellent interpersonal, verbal, and written communication skills.
Demonstrated collaborative skills and prior leadership experience.
Comfortable in a fast‑paced, small‑company environment with ability to adjust workload based on changing priorities.
Technical knowledge of analytical chemistry.
Proficiency in Microsoft Word, Excel, and Office.
Experience with contracting testing laboratories.
Preferred Experience
BS degree in a relevant life‑science, scientific, or engineering discipline.
3–5 years of laboratory experience in the pharmaceutical industry, Quality Control.
All duties, responsibilities, and activities may be subject to change at any time with or without notice.
EEO Statement
Tedor Pharma, Inc. is proud to be an Equal Employment Opportunity and affirmative action employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate based on race, religion, color, marital status, national origin, gender, sexual orientation, gender identity, gender expression, age, protected veteran status, ancestry, medical condition, pregnancy, genetic information, or any other status protected under federal, state, or local law.
#J-18808-Ljbffr
This position reports directly to the Quality Control Manager or Director and is responsible for managing and executing quality testing for drug substances in the commercial market, including method validation, release & stability testing for clinical trial and commercial drug products. The role ensures compliance with company policies, FDA regulations, and cGMP requirements, while maintaining accurate data review, analysis, and trending for raw materials, finished formulations, and stability samples.
Responsibilities
Lead collaboration between QC Analysts and Development Chemists, and cross‑department collaboration with drug product development, commercial operations, QA, and Analytical Development.
Evaluate QC laboratory operations and determine resources required to perform tests.
Generate, review, and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.).
Manage technical transfer of methods from internal labs for raw material analysis, in‑process testing, and API and drug product testing.
Review and report QC data, generate certificates of analysis, and monitor and trend data from internal and contract testing labs.
Initiate ICH stability study protocols and execute interim reports.
Manage and review out‑of‑specification or atypical result investigations, deviations, and CAPAs.
Investigate and troubleshoot method issues.
Review relevant sections of regulatory filings.
Monitor calibration schedules and maintain calibration data.
Contact vendors and schedule visits for PM/Calibration, repairs, and on‑site assistance.
Coordinate stability operations, determine sample requirements, develop stability protocols, and oversee execution.
Monitor stability chambers and chart recorders daily for environmental conditions and acceptance criteria.
Prepare stability data graphs, estimate expiration dates, and verify product shelf life.
Handle equipment qualification and data integrity programs.
Required Education & Experience
B.S. in Chemistry, Pharmaceutical Science, or related life‑science discipline.
5–7 years of laboratory experience in the pharmaceutical industry, QC.
3+ years of experience in a regulated manufacturing or QC laboratory performing analytical methods for pharmaceutical products.
Experience in QC testing of pharmaceutical and/or biologic products in a GMP environment.
Strong understanding of GMP compliance, CMC requirements for ANDAs, and regulatory filings.
Excellent interpersonal, verbal, and written communication skills.
Demonstrated collaborative skills and prior leadership experience.
Comfortable in a fast‑paced, small‑company environment with ability to adjust workload based on changing priorities.
Technical knowledge of analytical chemistry.
Proficiency in Microsoft Word, Excel, and Office.
Experience with contracting testing laboratories.
Preferred Experience
BS degree in a relevant life‑science, scientific, or engineering discipline.
3–5 years of laboratory experience in the pharmaceutical industry, Quality Control.
All duties, responsibilities, and activities may be subject to change at any time with or without notice.
EEO Statement
Tedor Pharma, Inc. is proud to be an Equal Employment Opportunity and affirmative action employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate based on race, religion, color, marital status, national origin, gender, sexual orientation, gender identity, gender expression, age, protected veteran status, ancestry, medical condition, pregnancy, genetic information, or any other status protected under federal, state, or local law.
#J-18808-Ljbffr