Senior Quality Assurance Specialist

Meitheal Pharmaceuticals Inc•Chicago, IL

3d•$84,000 - $100,000•Onsite

About The Position

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytic, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.

Requirements

Background in GMP/GDP, sterile injectables preferred, and experience with virtual/outsourced manufacturing.
In depth knowledge of cGMPs as well as FDA trends and guidelines.
Strong interpersonal skills and great attention to detail are necessary.
Must be a strong team player with good problem solving and good verbal and written communication skills.
Must be able to handle multiple projects concurrently.
Ability to manage indirect relationships and projects successfully.
Elevates issues to management, when appropriate.
Code of Federal Regulations and cGMP’s
Strong written and oral communications skills
Planning and Organizing
Interpersonal
Teamwork
Problem Solving
Quality Management
Judgement
Dependability
Ethics

Nice To Haves

TrackWise Digital preferred but not required.

Responsibilities

Performs review and approval of QA documentation for all Meitheal batch disposition activities, including: Batch Record review per the applicable review frequency, Abbreviated Batch Record review per the applicable review frequency, Review of COA, COC, and Quality documentation supporting shipment authorization of product manufactured for Meitheal prior to shipment, Review of Partner’s investigations for adequate root cause analysis, Review of temperature profiling data.
Performs life cycle management activities by reviewing partners Packaging Specifications and Packaging Assessments, performing Shipping Assessments and reviewing partner’s Process Validation protocols/reports for commercialized products.
Performs internal Quality Events including deviations, investigations and risk assessments, as needed.
Provide guidance and support in all aspects of cGMP to our Partners, including good documentation practices and root cause analysis during investigations.
Performs review and approval of QA documentation supporting New Product Launches, as needed.
Supports management during external inspections.
Remains current in regulatory trends and requirements.
Other duties, as assigned.