Quality Operations Specialist - Product Complaints

Description 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 $78,000 to $86,000 USD / 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 Quality Assurance Specialist – Quality Operations is primarily responsible for the Product Quality Complaint Program. Overseeing the intake, triage, and follow-up of all received Product Quality Complaints. This role ensures that all product complaints received are assessed in compliance with regulatory standards and internal procedures. This position will also assist in 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. Essential Duties and Responsibilities Coordinating the intake of Complaint and product Inquiries, as well as initial triage and facilitating risk assessment. Works cross-functionally with contract manufacturers in support of the Product Quality Complaint investigation including but not limited to requesting/Receiving Complaint Samples for further evaluation as needed. Provides support in preparing Annual Product review reports for each product on an annual basis. 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. 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. Education and/or Experience Bachelor’s in science or equivalent degree. 2-5 years’ experience in Quality and/or Manufacturing with 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. 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. #J-18808-Ljbffr