Senior Specialist, Quality Control (Incoming Materials)

Expectations Serves as a technical lead of Quality Control regarding incoming GMP material inspection and physical characterization testing. Collaborates with multiple Cardinal Health departments to coordinate and facilitate the packaging and shipment of materials to external service vendors for testing that cannot be performed on site and coordinates payment with procurement. Has knowledge and is able to execute work within the SAP system. Exhibits Cardinal Health's high ethical standards and code of conduct. Aligns work priorities with immediate supervisor. Approaches work situations with a positive and energizing style. Gains awareness of other departments at site. Seeks to understand the functions of those departments and the points of interaction between QC and your role. Exhibits professional conduct, respect for others, and understands how to be successful in a team environment. Actively participates in improving work processes to meet and exceed expectations, identifying opportunities for improvement. Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements, including maintaining required trainings as appropriate to position requirements. Is detail oriented, organized, has the ability to multi-task, and is self‑motivated. Is aware of internal/external business issues and adapts work priorities in own area. Demonstrates strong communication skills. Effectively listens to and explains difficult issues to reach shared understanding and build alignment. Has the ability to act calmly and patiently when working under pressure and/or conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives. Responsibilities Ensures timely and thorough inspections and analysis of incoming, raw, and GMP printed materials. Creates MIC codes and inspection plans in SAP system and material specifications within the document management system. Keeps track of purchase orders related to incoming materials. Follows standard operating procedures, analytical methods, and specifications and completes required documentation. Performs investigations, deviations, change controls, and CAPAs as applicable. Authors and optimizes SOPs, analytical testing forms, and other documents as necessary. Performs special projects or tasks as necessary based on skill set and/or development goals and business needs. Supports the Principal Specialist, Quality Control – Incoming Materials, to serve as the backup liaison between Quality Control and external service vendors and may assist in the scheduling of testing and timely receipt of reported results from external service vendors for the purpose of releasing incoming GMP material. Is a lead collaborator on behalf of Quality Control with different departments to coordinate and facilitate the packaging and shipment of materials to external service vendors for testing that cannot be performed on site. Authors laboratory investigations, change controls, deviations, and corrective/preventative actions as needed. Champions Quality, cGMP compliance, and EHS/Radiation Safety practices. Performs other job duties as assigned. Qualifications Bachelor’s degree or previous work experience in a similar role or related field, such as materials management or warehouse. 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device). Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations. Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills. Physical/Mental Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus. Work Environment The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility, the materials warehouse as well as the laboratory setting. The facility is operated under well‑controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate. Benefits Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401(k) savings plan Access to wages before pay day with myFlexPay Flexible spending accounts (FSAs) Short‑ and long‑term disability coverage Work‑Life resources Paid parental leave Healthy lifestyle programs Compensation Anticipated salary range: $68,500‑$88,020 Bonus eligible: No EEO Statement Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. #J-18808-Ljbffr