Duration - 12 months long project with possibility of extesnion
Pay - $35/hr to $39/hr
- The ideal candidate would possess BS in Chemical, Biochemical, Biomedical engineering or a BS in the life sciences.
- Entry level resources w/1-3 years of experience in the pharmaceutical/regulated industry is preferred – Direct or technical operations roles.
- Strong understanding/advanced knowledge of GMP/engineering documentation practices and design requirements for cGMP process.
- Familiar W/ Trackwise and or Change Control systems, multivariate data analysis tools, deviation management systems and process, CAPA investigations, batch record generation and review.
- Technology transfer experience a plus.
- Authoring/reviewing technical memo’s and reports. 3 years of experience writing change controls.
- Experience working with CMO's, project management skills/experience.
- Data focused - Data entry & data analysis. Phone/meeting/WebEx/Teams
- Execute manufacturing process change controls as part of product lifecycle.
- Investigate manufacturing deviations to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented. Perform data monitoring and trending.
- Provide filing/submission support by source documentation mapping and data audits. Author reports/ technical documents as needed.
- Join calls with CMO's, data monitoring group, supporting team through campaign readiness, run business activities for commercial management manufacturing.
- Deviation management.
- There are approximately 10 people on the team who are very collaborative and work well together. The team is expanding.
- Work with cross functional teams to develop & improve manufacturing systems to support utilizing cGMP process equipment while maintaining and improving quality standards. Develop or revise technical related forms and documents for process and manufacturing equipment.
- Schedule and oversee the performance of preventive maintenance work orders of cGMP equipment.
- Implements corrective/preventive actions for existing equipment and manufacturing processes.
- Prepare change control documentation. Write and modify procedures for the proper operation of new and/or existing equipment. You will also manage external partnerships.
cGMP process,technical operations,deviation management,CAPA investigations, batch record,Technology transfer experience,change controls