Senior Quality Assurance Specialist

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.

The estimated salary range for this position is $84,000 to $100,000 / year.

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.

What We Offer

• Competitive pay and medical, dental, and vision insurance
• Flexible spending accounts
• Long- and short-term disability insurance, as well as life insurance
• 401(k) plan with employer contribution
• Competitive PTO and company-paid holidays
• Paid parental leave (maternity & paternity)
• Onsite gym (Chicago office)

Position Summary

The Senior Quality Assurance Specialist works with our Partners to ensure Meitheal's standards and requirements are met for routine commercialized product shipments and distributions as well as providing support for all lifecycle management activities associated with commercialized products.

Essential Duties and Responsibilities

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

1. Batch Record review per the applicable review frequency.
2. Abbreviated Batch Record review per the applicable review frequency.
3. Review of COA, COC, and Quality documentation supporting shipment authorization of product manufactured for Meitheal prior to shipment.
4. Review of Partner's investigations for adequate root cause analysis.
5. 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.

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

Position Requirements

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.

• 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.

Education and/or Experience

• Bachelor's degree in science or equivalent degree.
• 3-5 years' experience in Quality with a pharmaceutical company or similarly regulated industry.

Travel

• No travel expected.

Physical Demands

• While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.

Computer Skills

• Microsoft Word, PowerPoint, Excel, TrackWise Digital preferred but not required.

AAP/EEO Statement

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

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