Analytical Quality Assurance Specialist

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.

Position Summary

The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities to include all CGMP activities and testing of any materials, intermediate/finished product, and any utility/facility testing. Working in a team environment, the AQA Specialist will provide oversite to ensure that all testing is performed in accordance with applicable procedures and compliance standards, ensure Data Integrity is maintained at all times, provide coaching and problem resolution from a Quality Assurance perspective, and act as primary reviewer of QC data for batch disposition. The AQA Specialist must be well organized and detail oriented, ensure quality events are raised in a timely manner as required.

Responsibilities

Ensure QC processes are controlled and monitored and identify and troubleshoot any quality issuesMonitor sample custody, in-process product samples, raw materials, and environmental monitoring (EM) samples, if applicableSupport in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocolsDocument activities with internal reportingIdentify training needs and take action to ensure company-wide complianceResponsible for the compilation and interpretation of QC Analytical data including OOSResponsible to ensure that established testing control procedures and good documentation practices are followedEnsure compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA

Education

Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalent

Experience

2 – 3 years in Quality Control, or equivalent

Knowledge And Skills

Excellent analytical skillsStrong knowledge of CFRsStrong interpersonal skillsExcellent verbal and written communication skillsAbility to work well in a team environmentAbility to work independentlyStrong problem-solving skillsStrong organizational skillsQuality certifications or training a plus