QC Supervisor

QC Lab Supervisor – 3rd Shift

The QC Supervisor oversees all quality control laboratory activities on the 3rd shift, ensuring accurate analytical support for routine processes and new products in a regulated GMP environment. This role accepts full responsibility for laboratory management during the shift, including equipment oversight, documentation control, and approval or rejection of materials and samples. The QC Supervisor leads a small team of analysts, promotes compliance with quality and safety systems, and drives continuous improvement within the laboratory.

Responsibilities include managing the QC laboratory during the 3rd shift and serving as the primary point of contact for all quality control activities; overseeing the maintenance and calibration of laboratory equipment to ensure accurate and reliable performance; managing documentation related to raw materials, intermediates, in-process controls (IPCs), stability, and cleaning samples in accordance with GMP and data integrity requirements; reviewing existing standard operating procedures (SOPs) and SOP qualifications (SOPQs), and writing or updating new procedures to reflect new equipment, technologies, and methods;

participating in the description of technical procedures and the review of analytical methods, ensuring they are current, clear, and compliant; initiating and managing change controls in documentation and systems, including quality control laboratory reports and related records; supporting the introduction and implementation of new work procedures within the laboratory, ensuring proper training and adherence; approving or rejecting raw materials, intermediates, IPCs, stability samples, and cleaning samples based on analytical results and applicable specifications;

preparing and reviewing analytical records in accordance with current SOPs and SOPQs for subsequent approval or rejection decisions; maintaining order, cleanliness, and organization within the laboratory to support safe and efficient operations; overseeing data entry and calculations in laboratory systems, ensuring accuracy and completeness, and generating analytical records and bulletins as needed; controlling and maintaining the sample library, ensuring proper storage, traceability, and retrieval of samples;

writing and investigating deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, and other laboratory events, documenting root causes and corrective actions; promoting and ensuring compliance with Health, Safety and Environment procedures, quality systems, GMP requirements, and data integrity principles following appropriate training; encouraging and implementing continuous improvement initiatives by identifying opportunities to enhance efficiency, resource utilization, and process robustness in the laboratory;

collaborating with laboratory leadership and cross-functional teams to support ongoing projects and customer work, aligning shift activities with broader organizational goals.

Qualifications include a degree in Sciences, preferably in Chemistry or Pharmacy; at least 3 years of chemistry laboratory experience in a GMP environment (such as food, pharmaceutical, medical device, or chemical industries); strong knowledge of analytical chemistry and wet chemistry techniques; hands-on experience with high-performance liquid chromatography (HPLC); experience with gas chromatography (GC) and related chromatographic techniques; familiarity with stability testing, raw material testing, intermediates, and in-process controls (IPCs);

working knowledge of GMP regulations and pharmaceutical or related industry quality systems; understanding and application of data integrity principles, including ALCOA and ALCOA+; experience performing data review, including audit trail review and verification of analytical results; ability to approve or reject raw materials, IPCs, stability samples, and cleaning samples based on defined specifications; proficiency with Microsoft Excel and Word for documentation, reporting, and data handling;

training or demonstrated knowledge in Health, Safety and Environment practices within a…