Analytical Quality Assurance Specialist(Microbiology)

Global Blockchain Talent; Monroe (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Glenmark Pharmaceuticals Inc. is seeking an Analytical Quality Assurance Specialist in Monroe, NC. This role is responsible for overseeing quality control processes in microbiology and chemistry, ensuring compliance with cGMP standards and USFDA regulations. A successful candidate will have a minimum of a Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or Microbiology and 2 to 3 years of experience in a quality control environment. Strong analytical, communication, and organizational skills are essential for success in this role.

Qualifications

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalent.
• 2 – 3 years in Quality Control, or equivalent.

Responsibilities

• Ensure QC processes are controlled and monitored and troubleshoot any quality issues.
• Monitor sample custody, in-process product samples, and environmental monitoring samples.
• Support development of method transfer and validation.
• Document activities with internal reporting.
• Identify training needs for company-wide compliance.
• Compile and interpret QC analytical data, including OOS analysis.
• Ensure established testing control procedures are followed.
• Ensure compliance with cGMP in the QC lab.

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

Strong problem-solving skills

Strong organizational skills

Quality certifications or training

Education

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

Job description

Analytical Quality Assurance Specialist (Microbiology)

Glenmark Pharmaceuticals Inc., USA, a subsidiary of Glenmark Pharmaceuticals Ltd., is a leading biopharma company engaged in the discovery and development of new chemical and biological entities, with a growing generics business and plans to enter the innovative market. Glenmark’s USA operations market APIs to both regulated and semi‑regulated countries.

The Analytical Quality Assurance (AQA) Specialist works with the Quality Control team as an in‑process quality assurance expert for microbiology and chemistry laboratory activities. The role includes overseeing CGMP activities, testing of materials, intermediate/finished products, and utility/facility testing; providing coaching and problem resolution from a Quality Assurance perspective; and acting as the primary reviewer of QC data for batch disposition. The AQA Specialist must be organized, detail‑oriented, and work promptly to raise quality events as needed.

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 development of method transfer and validation, troubleshooting, cross‑validation, and IQ/OQ protocols.
• Document activities with internal reporting.
• Identify training needs and take action to ensure company‑wide compliance.
• Compiling and interpreting QC analytical data, including OOS analysis.
• Ensure that established testing control procedures and good documentation practices are followed.
• Ensure compliance with data integrity and cGMP in the QC lab in line with USFDA standards.

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.