Quality Assurance

4 weeks ago


Chicago, United States Meitheal Pharmaceuticals Inc Full time
Job DescriptionJob DescriptionDescription:

About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.


Position Summary:

We are seeking a Quality Assurance Specialist to join our QA team. This role is essential in ensuring Meitheal’s standards and requirements are met for routine product shipments and distributions.


Key Responsibilities:


Performs review and approval of QA documentation for all Meitheal batch disposition activities, including:

  • Batch Record review per the applicable review frequency.
  • Review of COA, COC, and Quality documentation supporting shipment authorization of products manufactured for Meitheal prior to shipment.
  • Review of Partner’s investigations for adequate root cause analysis.
  • Review of temperature profiling data.
  • Disposition product.
  • Provide guidance and support in all aspects of cGMP to our Partners.
  • Remains current in regulatory trends and requirements.

Qualifications:


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Adapt to changing environments.
  • Ability to prioritize and multitask.
  • Organized and detailed orientated.
  • Has a sense of urgency to meet all required deadlines.
  • Ability to manage indirect relationships and projects successfully.
  • Elevates issues to management, when appropriate.

Education and/or Experience

  • Bachelor's degree in life sciences from 4-year college or university.
  • 1-3 years QA/QC experience in the pharmaceutical or related industry; or equivalent combination of education and experience.
  • Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines.
  • Strong interpersonal skills
  • Great attention to detail is necessary.

Preferred

  • Background in aseptic processing, preferably with injectables, and
  • Experience with complex generics, drug-device combination productions, biosimilars, or biologics is a plus.

Computer Skills

  • Proficient in Microsoft Office, Adobe Systems (Pro, Acrobat DC) and
  • Quality management systems (TrackWise) preferred but not required.

Why Join Us?

  • Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
  • Work in a collaborative and supportive environment that values teamwork and common goals.
  • Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
  • Hybrid schedule – two days in the office per week.
  • Casual dress code.

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.

Apply Now:

If you are passionate about Quality Assurance and want to contribute to a company that values innovation and teamwork, we want to hear from you Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

Requirements:




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