Senior Quality Control Analyst

About the role

This position is for a highly motivated member of the Quality Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager. The role involves performing QC analysis in compliance with cGMP standards prescribed by the USFDA, maintaining data integrity, and supporting various laboratory and quality systems.

Responsibilities

• Perform QC analysis in compliance with cGMP and USFDA standards.
• Maintain compliance with data integrity and cGMP in the QC lab.
• Perform Installation Qualification/Operational Qualification (IOQ) and calibration for instruments in the QC lab with guidance from Corporate Quality Assurance (CQA).
• Execute and complete procedures and systems for Raw Material (RM), Packaging Material (PM), Finished Drug (FD), and in-process testing in the QC lab.
• Provide information and data for evaluation and execution of stability studies as per quality and regulatory requirements.
• Ensure timely completion of testing and compliance during analytical Technology Transfer (TT) and Analytical Method Validation (AMV).
• Serve as a qualified trainer for QC-related systems and Standard Operating Procedures (SOPs), ensuring personnel are appropriately trained.
• Investigate quality events and perform Root Cause Analysis (RCA) as a member of the Site Investigation Team (SIT).
• Be cost-effective and vigilant regarding laboratory reagents, glassware, and other resources to ensure the department stays within the Revenue and Capex Budget.
• Maintain quality system controls to prevent critical and major market complaints.
• Reduce wastages and losses in the analysis process to improve efficiency.
• Perform day-to-day activities in the chemical laboratory, including testing of in-process, RM, PM, FP samples, swab samples, and technology transfer (as applicable).
• Ensure compliance with systems and procedures throughout the product lifecycle.
• Communicate with supervisors regarding any preparations or data that may result in Incidents or Out-of-Specification (OOS) results.
• Maintain the QC Laboratory in a state of compliance for internal and external audits.
• Execute technology transfer of analytical methods for new products and cleaning validation of new products.
• Monitor changes in Pharmacopoeia monographs, regulatory agency recommendations, and implement updates in the QC Lab.
• Apply Corrective and Preventive Actions (CAPA) for lab failures in OOS results.
• Maintain certified investigator training requirements for SIT representation.
• Investigate quality events using root cause analysis tools, maintain timelines for closure, and initiate CAPAs.
• Participate in continuous improvement initiatives for investigations and associated processes.
• Work with the Corporate Investigation Team (CIT) for major and critical investigations to align with corporate guidelines.
• Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
• Maintain knowledge of current regulatory requirements and standards for Stability and Quality Control departments.
• Represent Glenmark in FDA, notified body, internal, and other regulatory audits.
• Collaborate with the CMC team responsible for drug product development and support management as needed.
• Travel domestically and internationally up to 5% to accompany technical staff in factory acceptance and inspection of laboratory equipment.
• Train QC Analysts (entry-level positions).
• Deploy tracking systems for Stability Samples and Process Validation Samples.
• Use the Training Tracking Tool/Software for Quality Assurance and Quality Control.

Requirements

• A minimum of a Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or equivalent.
• 4+ years of experience in a pharmaceutical manufacturing facility.
• Background in Quality Control, including Stability, Finished Goods, and some Raw Materials, with experience in Analytical R&D.

Skills

• Extensive knowledge of general laboratory equipment, including GC, HPLC, Polarography, Particulate Matter, UV-Vis, and FTIR.
• Knowledge of cGMP, validations and qualifications, regulatory guidelines, US Pharmacopoeias, internal auditing, handling regulatory inspections, Quality Management Systems (QMS), change control, deviations, and market complaint management systems.
• Skills in coordinating calibration and preventative maintenance services, including setting up vendor contracts, processing quotes, generating purchase orders, and handling vendor invoices.
• Technical writing skills for generating SOPs and serving as a Subject Matter Expert.
• Certified Six Sigma Green Belt professional.
• Ability to support management in organizing and maintaining the QC team, strong communication skills, leadership, and GMP training.
• Experience dealing with multiple audits is an added advantage.