Glenmark Pharmaceuticals · 3 hours ago
Quality Control Analyst
Monroe, NC
Full-time
Onsite
Entry, Mid Level
1+ years expGlenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules. The Quality Control Analyst position involves performing QC analysis in compliance with cGMP and USFDA standards, maintaining data integrity, and ensuring compliance during analytical testing in the QC lab.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Be cost effective and vigilant of laboratory reagents, glassware, etcetera to ensure department is within the Revenue and Capex Budget as per spent analysis project
Provide feedback to management with 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 which shall include testing of in- process, RM, PM and FP samples, Swab sample and Tech Transfer (as applicable)
Ensuring 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 that 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 the monitoring of changes in the monographs Pharmacopoeia requirements, Regulatory agencies recommendations and implement the same in QC Lab
Apply CAPA for Lab failures in OOS
Prepare in timely fashion updating and revision of SOP, specification, STP and any other documents
Assist in timely completion of Tech Transfer of Finished products
Ensure training of QC staff
Perform the Tracking System Deployment for Stability Samples/ Process Validation Samples etc
Perform the Training Tracking Tool/Software for QUALITY Assurance and Quality Control
Qualification
Required
B.Sc. in Chemistry with concentration in Biochemistry
1-3 years in the field of Pharmaceutical (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 in 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, 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
Support the Management to organize and maintain the QC team, good communications skills, front runner, and GMP trainer
Preferred
Will be an added advantage if the individual has dealt with multiple audits personally
Began training under Six Sigma and Project Management
Company
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company.
10001+ employees
H1B Sponsorship
Glenmark Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (4)
2023 (1)
2022 (4)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$58MKey Investors
HDFC Mutual FundTrue NorthActis
2025-06-19Post Ipo Equity
2018-08-13Post Ipo Equity
2002-07-01Private Equity· $48M
Leadership Team
Brendan O'Grady
Chief Executive Officer
Rajeev Sharma
Senior Vice President Finance & CFO - North America
Recent News
2025-12-24
Business Standard India
2025-12-17
Company data provided by crunchbase