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Job Title Senior Quality Assurance Specialist Requisition JR000014050 Senior Quality Assurance Specialist (Open) Location Field Based Location - USA082 Additional Locations Bridgewater, NJ, Chicago, IL, Detroit, MI, Jacksonville, FL, Little Rock, AR, Louisville, KY, Nashville, TN, Omaha, NE, Philadelphia, PA, Raleigh, NC, Richmond, VA Job Description The Senior Quality Assurance Specialist supports externally manufactured products for Mallinckrodt with a product portfolio that includes pharmaceutical and biopharmaceutical products. The Senior Quality Assurance Specialist is responsible for building, maintaining and managing the relationship with their counterparts at the CMO and cross-functional MNK team members. The Senior Quality Assurance Specialist is responsible for appropriate escalation to Manager/Director level management and above. Essential Functions Batch Review Preparation, review and approval of CMO documentation for batch production Review of batch records, addressing discrepancies and escalating where required to management. Preparation of disposition and release certification for reviewed batch records CMO Governance Management and oversight of third-party supplier activities relating to the manufacture, packaging and testing of product. Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product. Continuous monitoring of product and performance from CMOs. Quality Support and Deputation Quality record management: deviations, change controls, CAPAs Monitoring cold-chain transportation, for both qualification and routine CMO Maintenance Input into Technical Quality Agreements Post-launch support for quality activities in various countries Management of delegated projects Stability Program Protocol review and approval Data review and management Audits Drive the audit readiness program to ensure audit compliance at all times. Quality/QMS Projects As required. Champion continuous improvement efforts for projects identified at the CMOs or within Mallinckrodt Minimum Requirements Bachelor's Degree in scientific discipline, 7+ years' experience working as QA Specialist required, 10+ years preferred Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems) Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485 Strong sterile manufacturing and/or microbiology background Excellent interpersonal skills: ability to communicate well, both verbally and written Demonstrate ability to work independently Thorough, diligent and good attention to detail Collaborator with strong levels of engagement with individuals and team High level of delivery and work completion Strong organizational skills Lead continuous improvement projects CQA and/or CSQP certification preferred. Organizational Relationship / Scope: The position reports to the Quality Operations Senior Manager. Working Conditions: This position works in an office type environment. Long periods of sitting are required. Use of computer and phone are required on a daily basis. This will require EST or CST working hours. Travel is expected routinely 1-2x per month. #LI-LM1 Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with app