Quality Assurance Specialist for Pharmaceutical Products

4 days ago


Philadelphia, Pennsylvania, United States Jobot Full time

About the Role

We are seeking an experienced Quality Assurance Specialist to join our team at Jobot. This is a fantastic opportunity to make a real impact in the pharmaceutical industry, ensuring the highest standards of quality control and compliance.

Responsibilities

The successful candidate will be responsible for:
  • Reviewing data from chemists to ensure adherence to internal Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
  • Developing specifications for raw materials, finished products, and stability studies.
  • Drafting analytical procedures, method validation protocols, stability protocols, and expiration memos.
  • Preparing Certificates of Analysis (COA) and Certificates of Conformance (COC).
  • Representing the Quality department in meetings, providing input and recommendations as needed.
  • Ensuring compliance with all safety protocols, familiarizing themselves with GMPs, ICH guidelines, FDA regulations, and other relevant regulatory requirements.
  • Initiating action or deviation reports for any identified nonconformances.
  • Conducting testing of raw materials, finished products, and additional samples as required.

Requirements

To be successful in this role, you will need:
  • Minimum 3 years of quality control or quality assurance experience.
  • Bachelor's degree in Biology, Chemistry, Biochemistry, or a related field, or equivalent technical/professional experience.
  • Experience in quality systems including validation, documentation, and compliance.
  • HPLC analytical experience is highly desirable.

What We Offer

In return for your expertise and dedication, we offer a competitive salary range of $55,000 - $65,000 per year, depending on your qualifications and experience.

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