Overview
Analytical Quality Assurance Specialist Jobs in Monroe, North Carolina, USA at Global Blockchain Talent
Career Opportunities with Glenmark Pharmaceuticals Inc.
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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCEs) 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 expand 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 experiencing significant growth both in the U.S. and internationally, positioning itself as a potential leading research-based pharmaceutical company.
POSITION SUMMARY:
The Analytical Quality Assurance (AQA) Specialist will collaborate with the Quality Control team, acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities. Responsibilities include all CGMP activities and testing of materials, intermediates, finished products, and utility/facility testing. The AQA Specialist will oversee testing processes, ensure compliance with procedures and standards, maintain Data Integrity, provide coaching and issue resolution from a QA perspective, and review QC data for batch disposition.
Organization, attention to detail, and timely quality event reporting are essential.
Responsibilities:
Control and monitor QC processes, troubleshoot quality issues
Monitor sample custody, in-process product samples, raw materials, and environmental monitoring samples
Support method transfer, validation, troubleshooting, cross-validation, and IQ/OQ protocols
Document activities and report internally
Identify training needs and promote company-wide compliance
Compile and interpret QC analytical data, including OOS
Ensure adherence to testing control procedures and good documentation practices
Maintain compliance with data integrity and cGMP standards as per USFDA
Education:
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalent
Experience:
2–3 years in Quality Control or related field
Knowledge and Skills:
Excellent analytical skills
Strong knowledge of CFRs
Effective interpersonal skills
Excellent verbal and written communication
Teamwork and independent working ability
Problem-solving skills
Strong organizational skills
Quality certifications or training are a plus
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Title: Analytical Quality Assurance Specialist
Company: Global Blockchain Talent
Location: Monroe, North Carolina, USA
Category: Quality Assurance – QA/QC, Pharmaceutical
