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Immunomedics, Inc. Manufacturing Specialist II (Upstream) in Morris Plains, New Jersey

Responsible for pharmaceutical manufacturing in compliance with current Good Manufacturing Practice (cGMP)

  • Ensures consistent completion of all the planned manufacturing activities assigned to him/herself.

  • Minimize waste of the resources (worktime, materials, and components).

  • Organize workplace to maximize the throughput and minimize risks of errors.

  • Follow well defined procedures closely, with attention to detail.

  • Practice strong aseptic technique.

  • Document activities accurately and clearly as per GDP.

  • Operate manufacturing equipment according to well defined procedures.

  • Daily monitoring of the process.

  • Minor maintenance of manufacturing equipment as trained.

  • Preparation of media, supplements, and/or buffers, where applicable.

  • Revise/draft standard operating procedures (SOPs) as necessary.

  • Report and document deviations, when encountered.

  • Assist with training new employees, where qualified.

  • Organize/trend data, where applicable.

  • Troubleshoot and recommend corrective/preventive actions (CAPAs), where applicable.

  • Ensures that organizational KPI’s are consistently achieved.

  • Draft deviations, CAPAs, and/or change controls, where requested.

  • Review completed manufacturing records for accuracy.

  • Revise manufacturing batch records, where applicable.

  • Supports shift activities are performed in accordance with the schedule.

  • Ensure compliance in operations.

  • Proactively communicate and escalate to management any outstanding issues, or concerns of a compliance, quality, safety, or any other critical matter.

  • High School Diploma required. Associates/Bachelor’s degree in the sciences or engineering discipline with 1 to 3 years’ experience in a cGMP manufacturing industry setting or 3 to 5 years of proven work experience.

  • Effective communication (oral and written), organizational, and interpersonal skills.

  • Ability to work well within a team environment.

  • Ability to document clearly and accurately as per GDP.

  • Ability to follow SOPs as written.

  • Possess strong aseptic technique.

  • Be proficient with MS Office.

  • Assist with training new manufacturing specialists as per established SOPs.

  • Have an aptitude for troubleshooting.

  • Be proactive in identifying, communicating and escalating issues.

  • Ability to closely review documentation as per GDP.

ID: 2020-1684

External Company Name: Immunomedics, Inc.

External Company URL: http://www.immunomedics.com

Street: 300 The American Road

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