Manufacturing Specialist - Upstream

Proclinical is currently recruiting for an Manufacturing Specialist of Upstream with a leading biotechnology company located in Morris Plains, NJ.

Job 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.

Skills and Requirements:

• 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.
• Ability to closely review documentation as per GDP.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at (+1) 215-531-5643 or c.nguyen@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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