Quality Assurance Specialist

About Us:

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, oncolytics, 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.

Position Summary:

The Quality Assurance Specialist is primary responsible for performing Annual Product reviews and generate the report for each product on an annual basis. This will require review and analysis of associated manufacturing, analytical and Quality data summaries provided by partners to compile the report within the required timeline. Previous experience with review of Manufacturing, Analytical and/or Quality data in a CGMP environment is a plus. The position may also assist with intake and processing of Product Inquiries and Complaints, as needed.

The compensation range for this position is $74,000 to $94,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Why Work with Us?

* Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

* Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

* Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

* Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

* Works in collaboration with contract manufacturing partners to obtain necessary documents, to complete Annual Product reviews.

* Review and critique CGMP documents with respect to accuracy, completeness, and compliance.

* Prepares Annual product review reports for each product on an annual basis.

* Provides support for other areas in the Quality department, including but not limited to, intake and processing of Product Inquiries and Complaints.

* Other tasks as assigned.

Supervisory - None

Competencies

* 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

Qualifications

* Bachelor's in science or equivalent degree.

* 2-5 years' experience in Quality and/or Manufacturing with a Pharmaceutical company or similarly regulated industry.

* Experience working in a cGMP production environment.

* Good interpersonal skills and great attention to detail are necessary.

* Must be a team player with good problem solving and good verbal and written communication skills.

* Has strong planning and organization skills.

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.