Manufacturing Support Specialist

The Manufacturing Support Specialist is responsible to facilitate the Deviation Reporting Program in Manufacturing Operations. This includes participating in a team to drive investigations related to manufacturing, packaging and equipment to determine root cause, impact, and corrective/preventative actions (CAPA). Essential Duties: Collaborates with manufacturing and packaging and other cross-functional team members to define root cause and provides recommendation for corrective and preventive actions. Monitors, investigates deviations and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging. process based upon trend, deviation and related analyses. Participates in daily Deviation meeting and provides updates to active, open deviation investigations. Coordinates follow-up activities necessary for closing deviation and CAPA investigations. Support internal, external and regulatory inspections including FDA, EMEA, and third-party audits related to the Deviation Reporting Program. Write and enhance applicable department SOP’s and guidelines. Responsible for technical writing activities to ensure clear concise investigation summaries. Education & Experience Requirements: A Bachelor’s degree is required with a minimum of 3 years’ experience working in manufacturing support or quality assurance role, preferably in a regulated industry. 2 years of technical writing experience required. Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category. At Upsher-Smith, we strive to help improve lives by bringing a variety of medications—both generics and brands—to patients and prescribers. Come join our dynamic pharmaceutical company, which offers challenging career opportunities for personal and professional growth in our offices, in our plants, and in every area in between. Click Here to return to the Career Site Home page