Quality Control Analyst

POSITION SUMMARY

This position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. Primary responsibilities for this position include performing QC analysis in compliance with cGMP and USFDA standards, maintaining data integrity, performing IOQ/Calibration for instruments with guidance of CQA, executing procedures for raw material (RM), process (PM), finished product (FP) and in-process testing, providing information for stability studies, ensuring timely testing and compliance during analytical throughput time (TT) and average monthly volumes (AMV), and serving as a qualified trainer for QC systems and SOPs, ensuring personnel are appropriately trained.

• Be cost effective and vigilant of laboratory reagents, glassware, etc. to ensure department is within the revenue and capital expenditure budget.
• Provide feedback to management on laboratory standard hours for financial prudence in resource planning, allocation and manpower to ensure within approved budgets while building best-in-class quality processes and systems at site.
• Execute and maintain quality system controls to ensure no critical and major market complaints.
• Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
• Perform day-to-day activities for the chemical laboratory, including testing of in-process, RM, PM and FP samples, swab samples and technology transfer (as applicable).
• Ensure compliance to systems and procedures throughout the product lifecycle.
• Communicate with supervisor or report any preparations or data that may result in an incidence or out-of-specification (OOS).
• Ensure the QC laboratory is in a ready state of compliance for internal and external audits.
• Execute technology transfer of analytical methods for new products and execute cleaning validation of new products.
• Assist in monitoring changes in monographs, pharmacopoeia requirements, regulatory agency recommendations and implement the same in QC lab.
• Apply CAPA for lab failures in OOS.
• Prepare updating and revision of SOPs, specifications, standard test procedures (STP) and other documents in a timely fashion.
• Assist in timely completion of technology transfer of finished products.
• Ensure training of QC staff.
• Perform the tracking system deployment for stability samples and process validation samples.
• Perform the training tracking tool/software for quality assurance and quality control.

B.Sc. in Chemistry with concentration in Biochemistry

1-3 years in the field of pharmaceuticals (manufacturing facility). Background in the functional areas of quality control in stability, finished goods and some raw materials, with some experience in R&D. Extensive knowledge of general laboratory equipment including, but not limited to, HPLC, UV‑Vis and FTIR.

Knowledge of cGMP, validations and qualifications, regulatory guidelines, US pharmacopoeias, internal auditing, handling of regulatory inspections, familiarity with QMS, change control/deviations and market‑compliant management systems. Skills in coordination of calibration and preventative maintenance services, including but not limited to setting up vendor contracts, processing quotes, generating purchase orders and handling vendor invoices. Technical writing skills to generate SOPs and serve as the subject matter expert.

Began training under Six Sigma and project management. Support management to organize and maintain the QC team, good communication skills, front runner, and GMP trainer.

Will be an added advantage if the individual has dealt with multiple audits personally.