Specialist I, Quality Assurance OperationsPosition Summary: Work Schedule: M-F 8am-5pm, 100% on‑site. Working for Catalent Biologics is an opportunity to join an entrepreneurial team dedicated to improving future patient outcomes through the development of drug products for conditions such as COVID‑19, cancer, autoimmune disorders, blood disorders, HIV, diabetes, heart and lung diseases, and Alzheimer's.RoleRepresent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, and related investigations, evaluations, and problem resolution.Lead continuous improvement projects for the Quality Assurance Operations department.Review Master Batch Production Records and material specifications for prepared solutions and columns.Oversee control and management of Cell Bank inventory.Provide review and approval of protocols and associated executed reports supporting Manufacturing operations, including media process simulations.Review and approve deviation investigation records.Provide training to Quality Assurance and Manufacturing personnel on quality topics.Maintain a sufficient understanding of quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.Support direct quality assurance oversight of routine manufacturing operations, including QA on the Floor, issuance of controlled documents, review of executed CGMP documentation, and disposition of prepared solutions and columns.Other duties as assigned.CandidateDoctorate degree in STEM discipline with minimum of 0 years related experience.Master's degree in STEM discipline with minimum of 4 years related experience.Bachelor's degree in STEM discipline with minimum of 6 years related experience.Associate's degree in STEM discipline with minimum of 10 years related experience.Ability to use Excel, Word, and other office systems.Prior experience with quality management software such as TrackWise or ComplianceWire.Ability to independently apply CGMPs to everyday work.Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.Executes procedures of high complexity with high quality.Advanced understanding of pharmaceutical laboratory and/or production operations.BenefitsDefined career path and annual performance review and feedback process.Diverse, inclusive culture.Positive working environment focusing on continually improving processes to remain innovative.Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.152 hours of PTO + 8 paid holidays.Generous 401K match.Medical, dental and vision benefits effective day one of employment.Tuition reimbursement.Catalent is an equal‑opportunity employer, including disability and veterans.#J-18808-Ljbffr