Production Supervisor

Company: AstraZeneca
Location: Frederick
Posted on: November 19, 2020

Job Description:

AstraZeneca Pharmaceuticals LP

Production Supervisor position available in Frederick, MD (full-time) to supervise and perform on-the-floor operations pertaining to biologics manufacture in a current Good Manufacturing Practices (cGMP) environment. Establish sequence of operations to produce product to adhere to the Master Production Plan. Administer and execute policies and procedures that typically affect individual subordinate employees. Review completed MPRs and SPRs to ensure Right First Time per compliance standards in a timely manner. Drive LEAN application for continuous Improvement of processing steps, eliminating waste in cost and time. Support Audit by creating document/ spreadsheets to support business reporting requirements. Collaborate with Manufacturing Process Lead to resolve problems, identify root cause, and propose process improvements through clear communication to senior management. Develop Standard Work for specified tasks. Lead multifunctional project teams. Evaluate and establish potential new interdepartmental procedures and practices. Review batch records and yield variance to identify process efficiency and accuracy. Ensure that projects are completed on schedule following established procedures and schedules. Coordinate Tier 1, shift change meetings to create cross-functional resource allocation needs for issues identified and maintain production targets.

Requirements: Bachelors degree in Science, Biology, Chemistry or related scientific field of study plus 5 years of progressively responsible experience as a Production Technician or other pilot or commercial biologics manufacturing role. Must be Yellow Belt certified. Must have five (5) years of progressively responsible experience with all of the following: Commercial biologics manufacturing under current Good Manufacturing Practices (cGMP) and Code of the Federal Regulations (CFR); Practical application of Current Good Manufacturing Practices (cGMPs); Utilizing and navigating SABA Cloud software; Transacting goods and receipts in SAP; Using Document Management System; Utilizing SCADA software; HMI portals using Rockwell Automation platform. Additionally, must possess two (2) years of experience in the following: Performing trouble shooting and root cause analysis; Utilizing GQCLIMS; Protein concentration analysis; Trackwise; Electronic batch records including PAS-X; and MODA. In the alternative, employer will accept a Masters degree in a stated field of study plus 3 years of experience.

Hours: Rotating 4day/3day biweekly overnight shifts (6pm -6am) plus alternating weekends.

Click Apply to submit your application. No calls please. EOE.

Keywords: AstraZeneca, Frederick , Production Supervisor, Other , Frederick, Maryland