Senior Quality Assurance Specialist

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: 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 partner’s 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. Provides 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 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. #J-18808-Ljbffr MEITHEAL PHARMACEUTICALS, INC