Experience

Aprecia Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Production Supervisor

  • Jul 2020 - Present

  • Ensure the product is being manufactured with strict adherence to all processing, Quality, Safety, and Environmental SOPs, batch records, guidelines, and policies. • Create daily schedule for direct reports. • Accountable for training of personnel on equipment, processes, and Standard Operating Procedures. • Initiate, investigate, and write deviations. • Trained in all areas (primary packaging, 3DP (three-dimensional printing) forming, compounding, dispensing, and blending/milling to successfully rotate between the functional duties and support changing production needs. • Promotes a positive work environment. • Ensures proper documentation practices are maintained consistently to company standards in manufacturing documents, training documentation, production logs, etc. • Set up, operate, monitor, and clean various equipment and their associated rooms.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Process Facilitator (Production Manager)

  • Nov 2018 - Nov 2019

  · Provided direction to personnel in the efficient use of equipment and materials to produce quality products. · Responsible for all coordination of support staff, scheduling, and improvements. · Promoted the use of safe work practices. · Accountable for training of personnel on equipment, processes, and Standard Operating Procedures. · Performed and assisted with monthly audits. · Promoted a positive work environment. · Initiated, investigated, and wrote deviations. · Reviewed and approved production forms and Standard Operating Procedures. · Promoted and encouraged continuous improvement. · Worked collaboratively to ensure flow of product, sharing of best practices, and lean behaviors.

• Process Facilitator (Production Manager)

  • May 2018 - Nov 2018

  · Responsible for process improvements.· Planned, scheduled and executed project improvements. · Responsible for all coordination of support staff, scheduling, and improvements. · Promoted the use of safe work practices. · Performed and assisted with monthly audits. · Promoted a positive work environment. · Initiated, investigated, and wrote deviations. · Reviewed and approved production forms and Standard Operating Procedures. · Promoted and encouraged continuous improvement. · Worked collaboratively to ensure flow of product, sharing of best practices, and lean behaviors.

• Manufacturing Lead

  • Jul 2015 - May 2018

  · Coordinated scheduled production activities and the activities of support groups working in the production area.· Led troubleshooting and process improvement activities.· Recommended and initiated maintenance activities to ensure area and equipment were maintained in a state of compliance.· Reviewed completed production documentation (Batch records, logbooks, etc.) for cGMP compliance.· Performed OJT for new and developing operators.· Provided input for production associate performance reviews.· Operated and maintain production equipment.· Assisted in execution of validation protocols for processes and equipment. · Performed production activities including line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, and operation of aseptic filling equipment.



Alkermes

• Ireland
• Biotechnology Research
• 700 & Above Employee

• Manufacturing Associate II

  • Apr 2015 - Jul 2015

  · Operated and maintained production equipment. · Troubleshoot process and equipment issues. · Complied with Good Manufacturing Practices and Standard Operating Procedures. · Properly completed production documentation (batch records, logbooks). · Reported to supervision when a process deviation or equipment issue occurred. · Performed production activities including line clearances, cleaning/sanitization. · Aseptic gown qualified. · Operated and maintained production equipment. · Troubleshoot process and equipment issues. · Complied with Good Manufacturing Practices and Standard Operating Procedures. · Properly completed production documentation (batch records, logbooks). · Reported to supervision when a process deviation or equipment issue occurred. · Performed production activities including line clearances, cleaning/sanitization. · Aseptic gown qualified.

• Filling Technician

  • Feb 2013 - Mar 2015

  · Operated and maintained production equipment. · Troubleshoot process and equipment issues. · Complied with Good Manufacturing Practices and Standard Operating Procedures. · Properly completed production documentation (batch records, logbooks). · Reported to supervision when a process deviation or equipment issue occurred. · Performed production activities including line clearances, cleaning/sanitization. · Aseptic gown qualified. · Operated and maintained production equipment. · Troubleshoot process and equipment issues. · Complied with Good Manufacturing Practices and Standard Operating Procedures. · Properly completed production documentation (batch records, logbooks). · Reported to supervision when a process deviation or equipment issue occurred. · Performed production activities including line clearances, cleaning/sanitization. · Aseptic gown qualified.



SUMCO

• Semiconductor Manufacturing
• 300 - 400 Employee

• Manufacturing Team Lead

  • 2008 - 2010

  · Filled in during supervisor absence. · Coached and helped develop team members. · Provided status reporting of team activities against program plans and schedules. · Worked in a cleanroom environment. · Diagnosed and repaired minor problems with equipment. · Worked on Kaizen teams. · Provided guidance to operators. · Performed preventative maintenance on equipment. · Monitored SPC charts to assure SPC rules were being followed. · Trained new operators on equipment. · Filled in during supervisor absence. · Coached and helped develop team members. · Provided status reporting of team activities against program plans and schedules. · Worked in a cleanroom environment. · Diagnosed and repaired minor problems with equipment. · Worked on Kaizen teams. · Provided guidance to operators. · Performed preventative maintenance on equipment. · Monitored SPC charts to assure SPC rules were being followed. · Trained new operators on equipment.