Analytical Quality Assurance Specialist

Global Blockchain Talent; Monroe (NC); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking an Analytical Quality Assurance Specialist to enhance quality control processes within their dynamic team. This role involves collaborating with the Quality Control team to ensure compliance with stringent standards and regulations. The ideal candidate will possess a strong background in pharmaceutical sciences, chemistry, or microbiology, and have a knack for analytical problem-solving. Join this innovative firm and contribute to maintaining the highest quality standards in a fast-paced environment, where your expertise will directly impact product integrity and safety.

Qualifications

• 2-3 years in Quality Control or related field.
• Strong knowledge of cGMP standards and data integrity.

Responsibilities

• Control and monitor QC processes, troubleshoot quality issues.
• Compile and interpret QC analytical data, including OOS.
• Ensure adherence to testing control procedures and good documentation practices.

Skills

Analytical Skills

Knowledge of CFRs

Interpersonal Skills

Verbal Communication

Written Communication

Teamwork

Problem-solving

Organizational Skills

Education

Bachelor's degree in Pharmaceutical Sciences

Bachelor's degree in Chemistry

Bachelor's degree in Microbiology

Job description

Career Opportunities with Glenmark Pharmaceuticals Inc.

A great place to work.

Share with friends or Subscribe!

Current job opportunities are posted here as they become available.

Subscribe to our RSS feeds to receive instant updates as new positions become available.

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCEs) 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 expand 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 experiencing significant growth both in the U.S. and internationally, positioning itself as a potential leading research-based pharmaceutical company.

POSITION SUMMARY:

The Analytical Quality Assurance (AQA) Specialist will collaborate with the Quality Control team, acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities. Responsibilities include all CGMP activities and testing of materials, intermediates, finished products, and utility/facility testing. The AQA Specialist will oversee testing processes, ensure compliance with procedures and standards, maintain Data Integrity, provide coaching and issue resolution from a QA perspective, and review QC data for batch disposition. Organization, attention to detail, and timely quality event reporting are essential.

Responsibilities:

• Control and monitor QC processes, troubleshoot quality issues
• Monitor sample custody, in-process product samples, raw materials, and environmental monitoring samples
• Support method transfer, validation, troubleshooting, cross-validation, and IQ/OQ protocols
• Document activities and report internally
• Identify training needs and promote company-wide compliance
• Compile and interpret QC analytical data, including OOS
• Ensure adherence to testing control procedures and good documentation practices
• Maintain compliance with data integrity and cGMP standards as per USFDA

Education:

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalent

Experience:

2–3 years in Quality Control or related field

Knowledge and Skills:

• Excellent analytical skills
• Strong knowledge of CFRs
• Effective interpersonal skills
• Excellent verbal and written communication
• Teamwork and independent working ability
• Problem-solving skills
• Strong organizational skills
• Quality certifications or training are a plus