Sterile Injectable Supervisor
Sterile Injectable Supervisor Department:
Production Location:
Monroe, NC START YOUR APPLICATION (https:
//apply.
hrmdirect.
com/resumedirect/ApplyOnline/Apply.
aspx?req_id=2624048&source=2624048-CJB-0) The Sterile Injectables Supervisor is responsible for the manufacturing of sterile liquids for commercial distribution in accordance with the schedule put forward by production leadership.
The position is considered a -working supervisor- position meaning that personnel in this role will train, organize and lead team members to complete daily operation requirements as well operate manufacturing processing equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices.
In addition, personnel in this position will employ acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning.
Personnel in this position will serve as SOP and BPR subject matter experts reviewing, closing out, and revising these documents as deemed required by production leadership.
Review and correction of area specific executed batch records and log books to meet timely closure of the documents.
Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines.
Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams.
Gathers all necessary CoA/CoC and lab results to close out area specific batch records.
Leads daily meetings to communicate day-s activities and production needs.
The Sterile Injectables Supervisor is responsible for the manufacturing of sterile liquids for commercial distribution in accordance with the schedule put forward by production leadership.
The position is considered a -working supervisor- position meaning that personnel in this role will train, organize and lead team members to complete daily operation requirements as well operate manufacturing processing equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices.
In addition, personnel in this position will employ acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning.
Personnel in this position will serve as SOP and BPR subject matter experts reviewing, closing out, and revising these documents as deemed required by production leadership.
Review and correction of area specific executed batch records and log books to meet timely closure of the documents.
Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines.
Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams.
Gathers all necessary CoA/CoC and lab results to close out area specific batch records.
Leads daily meetings to communicate day-s activities and production needs.
Communicates effectively with area leadership and cross-functional departments including maintenance, QC microbiology, QC chemistry and IPQA to align production needs and ensure timely completion of production schedule.
Identifies deviations in real time handling write up of the issue and investigation in the QMS, taking guidance from IPQA, QEM and production leadership.
Has mastery of all aseptic processing concepts and steps including aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization.
Possesses competitive, detailed oriented production mentality and is not satisfied by anything less than perfection.
Thinks creatively within the bounds of CGMP framework to overcome challenges and brings viable solutions to the table.
Documents batch statistics within SAP.
Serves as area specific SME developing, revising and approving all manner of CGMP framework including protocols, SOP-s, BMR-s, risk assessments and summary reports.
Provides training to other operators.
Follows written procedures.
Clearly and accurately documents activities.
Performs basic math calculations.
Submits in-process samples to responsible departments.
Performs cleaning of rooms, tools and equipment as needed.
Responsible to ensure that the product meets specification.
Attain and maintain Aseptic Gown Certification.
Operate Autoclave to prepare/sterilize supplies as needed.
Read, understand and review SOP-s and Protocols as required.
Education Associate/Bachelor Degree preferred Experience 5 - 7 Years- experience in CGMP/Aseptic Operations Background Knowledge & Skills FDA/CGMP/Mechanical Aptitude/Process SME Leadership/Managerial attributes Working Lead, sets tone for area specific production group Other requirements Flexible, able to work overtime when needed.
START YOUR APPLICATION (https:
//apply.
hrmdirect.
com/resumedirect/ApplyOnline/Apply.
aspx?req_id=2624048&source=2624048-CJB-0) Recommended Skills Attention To Detail Calculations Communication Good Manufacturing Practices Leadership Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
Production Location:
Monroe, NC START YOUR APPLICATION (https:
//apply.
hrmdirect.
com/resumedirect/ApplyOnline/Apply.
aspx?req_id=2624048&source=2624048-CJB-0) The Sterile Injectables Supervisor is responsible for the manufacturing of sterile liquids for commercial distribution in accordance with the schedule put forward by production leadership.
The position is considered a -working supervisor- position meaning that personnel in this role will train, organize and lead team members to complete daily operation requirements as well operate manufacturing processing equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices.
In addition, personnel in this position will employ acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning.
Personnel in this position will serve as SOP and BPR subject matter experts reviewing, closing out, and revising these documents as deemed required by production leadership.
Review and correction of area specific executed batch records and log books to meet timely closure of the documents.
Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines.
Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams.
Gathers all necessary CoA/CoC and lab results to close out area specific batch records.
Leads daily meetings to communicate day-s activities and production needs.
The Sterile Injectables Supervisor is responsible for the manufacturing of sterile liquids for commercial distribution in accordance with the schedule put forward by production leadership.
The position is considered a -working supervisor- position meaning that personnel in this role will train, organize and lead team members to complete daily operation requirements as well operate manufacturing processing equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices.
In addition, personnel in this position will employ acceptable aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning.
Personnel in this position will serve as SOP and BPR subject matter experts reviewing, closing out, and revising these documents as deemed required by production leadership.
Review and correction of area specific executed batch records and log books to meet timely closure of the documents.
Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines.
Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams.
Gathers all necessary CoA/CoC and lab results to close out area specific batch records.
Leads daily meetings to communicate day-s activities and production needs.
Communicates effectively with area leadership and cross-functional departments including maintenance, QC microbiology, QC chemistry and IPQA to align production needs and ensure timely completion of production schedule.
Identifies deviations in real time handling write up of the issue and investigation in the QMS, taking guidance from IPQA, QEM and production leadership.
Has mastery of all aseptic processing concepts and steps including aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization.
Possesses competitive, detailed oriented production mentality and is not satisfied by anything less than perfection.
Thinks creatively within the bounds of CGMP framework to overcome challenges and brings viable solutions to the table.
Documents batch statistics within SAP.
Serves as area specific SME developing, revising and approving all manner of CGMP framework including protocols, SOP-s, BMR-s, risk assessments and summary reports.
Provides training to other operators.
Follows written procedures.
Clearly and accurately documents activities.
Performs basic math calculations.
Submits in-process samples to responsible departments.
Performs cleaning of rooms, tools and equipment as needed.
Responsible to ensure that the product meets specification.
Attain and maintain Aseptic Gown Certification.
Operate Autoclave to prepare/sterilize supplies as needed.
Read, understand and review SOP-s and Protocols as required.
Education Associate/Bachelor Degree preferred Experience 5 - 7 Years- experience in CGMP/Aseptic Operations Background Knowledge & Skills FDA/CGMP/Mechanical Aptitude/Process SME Leadership/Managerial attributes Working Lead, sets tone for area specific production group Other requirements Flexible, able to work overtime when needed.
START YOUR APPLICATION (https:
//apply.
hrmdirect.
com/resumedirect/ApplyOnline/Apply.
aspx?req_id=2624048&source=2624048-CJB-0) Recommended Skills Attention To Detail Calculations Communication Good Manufacturing Practices Leadership Maintenance Estimated Salary: $20 to $28 per hour based on qualifications.
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