Analytical QA Specialist - CGMP & Data Integrity

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Glenmark Pharmaceuticals, Inc., USA is seeking an Analytical Quality Assurance (AQA) Specialist to join the Quality Control team on the floor as an in-process quality assurance expert for microbiology and chemistry activities, including CGMP testing and batch disposition.

The role emphasizes Data Integrity, coaching on quality issues, and primary review of QC data, with strong CFR knowledge, excellent communication, and the ability to work in a team in a fast-growing facility.

Qualifications

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalent
• 2–3 years in Quality Control, or equivalent
• Excellent analytical skills and strong knowledge of CFRs

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

Skills

Analytical skills

CFR knowledge

Interpersonal skills

Communication skills

Team player

Independence

Problem-solving

Organizational skills

Quality certifications

Education

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

Job description

Glenmark Pharmaceuticals, Inc., USA is seeking an Analytical Quality Assurance (AQA) Specialist to join the Quality Control team on the floor as an in-process quality assurance expert for microbiology and chemistry activities, including CGMP testing and batch disposition.

The role emphasizes Data Integrity, coaching on quality issues, and primary review of QC data, with strong CFR knowledge, excellent communication, and the ability to work in a team in a fast-growing facility.