Kelly Science, Engineering, Technology & Telecom
Quality Control Laboratory Supervisor
Kelly Science, Engineering, Technology & Telecom, Trenton, New Jersey, us, 08628
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Overview The
QC Chemistry Supervisor
will lead all Quality Control Chemistry laboratory operations to support GMP manufacturing, testing, and release of raw materials, intermediates, and finished products in compliance with FDA, EU, and international regulatory standards.
Key Responsibilities
Lead and manage the setup and operationalization of a new QC Chemistry laboratory. Conduct or supervise bench-level testing as needed.
Oversee daily QC Chemistry lab operations, ensuring timely and accurate testing for in-process materials, drug substance (DS), drug product (DP), and stability samples. Maintain compliance with FDA, EU and cGMP requirements.
Oversee the development and implementation of SOPs, test methods, specifications, and related documentation.
Lead and manage investigations related to OOS results, deviations, laboratory errors, and instrument malfunctions; implement effective CAPAs.
Manage and coordinate method transfers and method validation/verification activities, including strategy development and protocol/report approvals.
Required Qualifications
Bachelor’s or advanced degree in Chemistry, Biochemistry, Pharmaceutical
Minimum 5–7 years of relevant industry experience in a cGMP-regulated pharmaceutical or biotechnology environment. Must have experience in Capillary Electrophoresis.
At least 2 years of leadership or supervisory experience in a QC laboratory setting.
Strong working knowledge of analytical techniques including HPLC, UHPLC, size exclusion chromatography, capillary electrophoresis, cIEF, peptide and oligo mapping, etc. Familiarity with USP, EP, and ICH guidelines.
Experience with analytical method validation, method transfers, and instrument qualification (IQ/OQ/PQ). Proficiency with laboratory documentation systems and software (e.g., LIMS, Empower, chromatography data systems).
In-depth understanding of cGMP/GLP principles and regulatory expectations
High attention to detail with a commitment to data integrity and quality.
Seniority level Mid-Senior level
Employment type Full-time
Job function
Science, Research, and Manufacturing
Industries
Pharmaceutical Manufacturing
Chemical Manufacturing
Biotechnology Research
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Overview The
QC Chemistry Supervisor
will lead all Quality Control Chemistry laboratory operations to support GMP manufacturing, testing, and release of raw materials, intermediates, and finished products in compliance with FDA, EU, and international regulatory standards.
Key Responsibilities
Lead and manage the setup and operationalization of a new QC Chemistry laboratory. Conduct or supervise bench-level testing as needed.
Oversee daily QC Chemistry lab operations, ensuring timely and accurate testing for in-process materials, drug substance (DS), drug product (DP), and stability samples. Maintain compliance with FDA, EU and cGMP requirements.
Oversee the development and implementation of SOPs, test methods, specifications, and related documentation.
Lead and manage investigations related to OOS results, deviations, laboratory errors, and instrument malfunctions; implement effective CAPAs.
Manage and coordinate method transfers and method validation/verification activities, including strategy development and protocol/report approvals.
Required Qualifications
Bachelor’s or advanced degree in Chemistry, Biochemistry, Pharmaceutical
Minimum 5–7 years of relevant industry experience in a cGMP-regulated pharmaceutical or biotechnology environment. Must have experience in Capillary Electrophoresis.
At least 2 years of leadership or supervisory experience in a QC laboratory setting.
Strong working knowledge of analytical techniques including HPLC, UHPLC, size exclusion chromatography, capillary electrophoresis, cIEF, peptide and oligo mapping, etc. Familiarity with USP, EP, and ICH guidelines.
Experience with analytical method validation, method transfers, and instrument qualification (IQ/OQ/PQ). Proficiency with laboratory documentation systems and software (e.g., LIMS, Empower, chromatography data systems).
In-depth understanding of cGMP/GLP principles and regulatory expectations
High attention to detail with a commitment to data integrity and quality.
Seniority level Mid-Senior level
Employment type Full-time
Job function
Science, Research, and Manufacturing
Industries
Pharmaceutical Manufacturing
Chemical Manufacturing
Biotechnology Research
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