Manufacturing Specialist - Upstream
Proclinical is currently recruiting for an Manufacturing Specialist of Upstream with a leading biotechnology company located in Morris Plains, NJ.
- 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 firstname.lastname@example.org.
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.