Manufacturing Operator - Night Shift bei PCC-India-Information Technology
PCC-India-Information Technology · Lexington, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Lexington
Business: Pharma Solution
Department: Operations
Location: Lexington
The Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.
- comply with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies
- Performs line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
- Operate and maintain production related equipment
- Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities
- Execute validation protocols for processes and equipment
- Maintain records and a clean environment to comply with regulatory requirements
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
- Review current SOPs and provide feedback on potential process improvements
- Participate in troubleshooting and process improvement activities including corresponding documentation activities
- Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance
- Initiate appropriate action when process deviations occur
- Perform on-the-job training for new and developing operators
- Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment
- Collaborate effectively and communicate with other functional groups, including: quality, validation, supply chain to ensure production goals are achieved
• 2+ years’ working within an industrial or manufacturing environment
• Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred
- Mechanical aptitude, ability to operate processing equipment
- Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
- Ability to read, interpret, and follow written instructions
- Team player committed to quality and working effectively with others
- Track record of consistent attendance and overall reliability