Microbiology QA Specialist | CGMP & Data Integrity

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

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.