Berkshire Sterile Manufacturing 480 Pleasant St, Lee, MA 01238 June 2018- current

Manufacturing Supervisor

Supervise a team of manufacturers in the formulation, filling, and lyophilization of sterile product.

Optimize manufacturing operations to maintain the production schedule.

Meet timelines and deliverables for quarterly and monthly goals.

Drive enhancements to improve Quality systems, training programs, and machine functionality.

Define and ensure adherence to quality systems, standards of procedures, and area budget.

Interface with supply chain, engineering, and project managers to accomplish department goals.

Write and revise S.O. P’s, Protocols, Job Aids, Reports, Media Fills.

Review pre and post run batch records, reports, and protocols for compliance to procedures.

Conduct business in a manner that complies with all state, FDA, OSHA, and HIPPAA regulations.

Berkshire Sterile Manufacturing 480 Pleasant St, Lee, MA 01238   Dec 2017- June 2018

Manufacturing Process Lead

Lead the formulation, filling, and lyophilization of pharmaceutical product.

Lead the daily operation of clean room and associated areas to ensure production schedule.

Maintain sterility in grade A environments using proper aseptic technique.

Effectively interface with the supply chain, engineering, and maintenance.

Operate autoclave and depyrogenation oven to sterilize tools and equipment.

Participate in validation, engineering studies, and media fills.

Write and review SOPs, batch records, excursions, OOS’s, change controls, and deviations.

Follow all GMP and safety procedures.

Familiar with technical issues in areas as the subject matter expert.

Train and ensure employees are trained on current procedures and practices.

Maintain qualification and perform visual inspection.

Onyx Specialty Papers  40 Willow St, Lee, MA 01238     September 2012-December 2016

Spare Quality control technician/ Machine room

Maintain I.S.O 9001 procedures.

Maintain constant P.H levels of paper being manufactured.

Report directly to machine operatos their current test specifications of paper being produced.

Visually inspect paper for defects to problem solve and eliminate the source.

Calibrate test equipment for daily activities.

Stay on a constant on call basis to cover any call outs or scheduling problems.

Operate a hydraulic press to make plate laminate for the customer.

Operate a Rewinder to eliminate defects in the paper made.

Assist in winder operations during difficult paper runs.

Wrap the finished product, lift with a clamp truck and place in trailer.

Assist in monthly and quarterly safety inspections.

AS in Business Management                *Pursuing

Certification in Culinary Arts                         2012

Professional Skills Profile

GMP professional versed in great documentation and technical writing.

Great leadership skills applied through various supervisor roles.

Team oriented with strong verbal and written communication skills.

Practiced in L.E.A.N manufacturing.

Licensed boiler operator.

Facility and supporting system experience.

Crane/hoisting experience.

Clamp and fork truck experience.

Experienced in L.O.T.O, E.H.S, and biohazard disposal.

Analytical quality control experience.

Participated in rotating swing shifts with impeccable attendance.

Experienced in Laboratory practices, and documentation.

10 years GMP experience

Professional References

Work History

References available for all previous employment upon request,

Department of Conservation and Recreation.    Summer 2018

Hillcrest Health Systems.                                   2012-2013

Rue 21, Inc                                                         2008-2012

Classical Tents and Party goods                       2004-2008

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