Senior Quality Control Analyst

Glenmark Pharmaceuticals•Monroe, NC

5d•Onsite

About The Position

Glenmark Pharmaceuticals Inc., USA is seeking a highly motivated Senior Quality Control Analyst to join the QC Lab at the Monroe manufacturing facility. This role reports to the QC Manager and is crucial for ensuring compliance with cGMP standards and USFDA regulations. The position involves performing QC analysis, maintaining data integrity, executing instrument qualifications and calibrations, and managing various testing procedures for raw materials, packaging materials, finished goods, and in-process samples. The analyst will also support stability studies, analytical transfers, and serve as a qualified trainer for QC systems and SOPs. Additionally, the role involves participating in the Site Investigation Team (SIT) to investigate quality events and perform Root Cause Analysis (RCA).

Requirements

Bachelor's degree in Chemistry / Pharmaceutical Sciences or Equivalent.
4+ years in the field of Pharmaceutical (manufacturing facility).
Background in the functional areas of Quality Control in Stability, Finished Goods and some Raw Materials.
Some experience in Analytical R&D.
Extensive knowledge in general laboratory equipment including but not limited to: GC, HPLC, Polarography, Particulate Matter, UV-Vis and FTIR.
Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections.
Well acquainted with QMS, well versed with Change control/deviations and market compliant management system.
Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices.
Technical writing skills to generate SOPs and serve as the Subject Matter Expert.
Completed training on Six Sigma, certified Green belt professional.
Good communication skills.
Front runner.
GMP trainer.

Nice To Haves

Domestic and international travel up to 5% may be required to accompany technical staff in the factory acceptance and inspection of laboratory equipment.
Will be an added advantage if the individual has dealt with multiple audits personally.

Responsibilities

Perform QC analysis in compliance with cGMP and USFDA standards.
Maintain compliance to data integrity and cGMP in the QC lab.
Perform IOQ/Calibration for instruments in the QC lab with guidance.
Execute and complete procedures and systems for RM, PM, FD, and in-process testing.
Provide information and data for evaluation and execution of stability studies.
Timely complete testing and ensure compliance during analytical TT and AMV.
Act as a qualified trainer for QC related systems and SOPs.
Investigate quality events and perform Root Cause Analysis (RCA) as a member of the Site Investigation Team (SIT).
Be cost-effective and vigilant of laboratory reagents, glassware, etcetera to ensure department is within the Revenue and Capex Budget.
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, FP, and Swab samples, and Tech Transfer.
Ensure compliance to systems and procedures throughout product lifecycle.
Communicate with Supervisor and/or report any preparations or data that may result in an Incidence & 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.
Execute cleaning validation of new products.
Assist in monitoring changes in Pharmacopoeia requirements and Regulatory agency recommendations and implement them in the QC Lab.
Apply CAPA for Lab failures in OOS.
Complete and maintain certified investigator training requirements for SIT representation.
Perform the investigation of quality events assigned using root cause analysis tools, maintain timelines for closure, and identify and initiate CAPAs.
Participate in continuous improvement initiatives for investigations and the associated investigation certification process.
Work with CIT team as needed for Major and Critical Investigations.
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.
Work in collaboration and support with other members of the CMC team.
Support management, as necessary.
Ensure training of QC Analyst (Entry level Positions).
Perform the Tracking System Deployment for Stability Samples/Process Validation Samples etc.
Perform the Training Tracking Tool/Software for QUALITY ASSURANCE and Quality Control.