Immunomedics, Inc.

Manufacturing Specialist II (Upstream)

Job Locations US-NJ-Morris Plains
Posted Date 2 weeks ago(5/21/2020 11:43 AM)
Job ID
2020-1684
# of Openings
1
Category
Scientific Manufacturing/Production

Overview

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

Responsibilities

  • 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.

Qualifications

  • 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.

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