Analytical Microbiology QA Specialist — Data Integrity

Glenmarkpharma; Monroe (NC); On-site; USD 75,000 - 95,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA is seeking an Analytical Quality Assurance Specialist to join the Quality Control team. You will act as an in-process QA expert for microbiology and chemistry laboratory activities, ensuring CGMP compliance, data integrity, and timely quality events reporting.

Responsibilities include monitoring QC processes, sample custody, method transfer support, documentation, and batch disposition review.

Qualifications

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalent.
• 2–3 years in Quality Control or equivalent.
• Strong knowledge of CFRs.
• Excellent analytical skills.
• Excellent verbal and written communication skills.
• Ability to work well in a team environment.
• Ability to work independently.
• Quality certifications or training a plus.
• Strong problem-solving skills.
• Strong organizational skills.

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

Verbal & written communication

Teamwork

Independence

Problem-solving

Organizational skills

Quality certifications

Education

BS/BA in Pharmaceutical Sciences/ Chemistry/ Microbiology

Job description

Glenmark Pharmaceuticals Inc., USA is seeking an Analytical Quality Assurance Specialist to join the Quality Control team. You will act as an in-process QA expert for microbiology and chemistry laboratory activities, ensuring CGMP compliance, data integrity, and timely quality events reporting.

Responsibilities include monitoring QC processes, sample custody, method transfer support, documentation, and batch disposition review.