Analytical Quality Assurance Specialist (Microbiology)

Department: Analytical QA

Location: Monroe, NC

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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 (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 issues

• Monitor sample custody, in-process product samples, raw materials, and environmental monitoring (EM) samples, if applicable

• Support in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols

• Document activities with internal reporting

• Identify training needs and take action to ensure company-wide compliance

• Responsible for the compilation and interpretation of QC Analytical data including OOS

• Responsible to ensure that established testing control procedures and good documentation practices are followed

• Ensure compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA

• Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits

• Review of equipment and instrument qualification, calibration, and preventive maintenance, as assigned

• Ensure all monitoring of equipment, utilities and facility is being performed in a CGMP manner, in accordance with site SOP

• Review completion of Tech Transfer of Finished products

• Prepare QC Data Review metrics as applicable

  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 skills

• Strong knowledge of CFRs

• Strong interpersonal skills

• Excellent verbal and written communication skills

• Ability to work well in a team environment

• Ability to work independently

• Strong problem-solving skills

• Strong organizational skills

• Quality certifications or training a plus

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