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.
External Company Name: Immunomedics, Inc.
External Company URL: http://www.immunomedics.com
Street: 300 The American Road