Quality Assurance Control

CAREER OJECTIVE

To attain the position of Supervisor for the (GM), (Bowling Green, Ky) facility

PROFESSIONAL EXPERIENCE

Alkermes, Inc., Wilmington, OH

Supervisor, 03/25/2012-Present

• Acts as operational leader on the floor for assigned shift with direct responsibility for Manufacturing Associates and operations

• Provides effective, ‘hands-on’ leadership to the production team as a whole in the production of pharmaceutical drug product

• Plans and supervises daily execution of tasks to support published production plan and supervises completion of work

• Supervise the GMP formulation of commercial scale batches; Ensures compliance with cGMP in the manufacture of products

• Supports the Line Manager complying with identified responsibilities (RACI)

• Ensures robust and timely communication of defined operational/planning activities associated with the execution of daily production

• Drives/Writes/Approves new SOPs, batch records, protocols in support of equipment and manufacturing processes

• Direct interface with support groups, including Facility & Process Maintenance, Engineering, Quality Assurance, Quality Control, Planning, Warehousing and Process Development, to ensure the operational status of the manufacturing area and production schedule

• Supports quality investigations, continuous improvement efforts and support group activities as they directly impact the functionality of the manufacturing area

• Initiate appropriate action when deviations occur, authoring investigations when required, to ensure the timely release of product and/or continuity of operation of the manufacturing line

• Support and perform validation efforts related to process improvements

• Ensure maintenance and upkeep of the facility and process employed within the area of responsibility

• In conjunction with Manufacturing training support, ensure opportunities for training for new and current operators

• Ensure qualification of operators, consistent with SOP, to support cGMP manufacturing of pharmaceutical product

• Supervise, develop and evaluate Manufacturing Associates

• General knowledge of and ability to participate in customer, internal and FDA audits

• General knowledge of and ability to participate in SAP activities

Alkermes, Inc., Wilmington, OH

Senior Operator Production, 04/18/2005 – 03/25/2012

• Production of pharmaceutical commercial batches.

• Assist with facility cleaning and operational maintenance.

• Assist with facility and process validations as required.

• Perform aseptic production operations and validations.

• Assist with environmental and water system monitoring as required.

• Assist with clean room sanitization as required.

Pfizer, Inc, Franklin, Oh

Senior Operator, 08/1988- 08/2002

• Lead other operators and small groups as directed by team leader.

• Production of pharmaceutical commercial batches.

• Assist with facility cleaning and operational maintenance.

• Assist with facility and process validations as required.

•• Assist with environment and water system monitoring as required.

• Assist with clean room sanitization as required.

Ran distillery for reprocessing of waste Alcohol.

EDUCATION & CREDENTIALS

Graduated from Monroe High, Ohio

CERTIFICATIONS

OPEX Lean Six Sigma Greenbelt, 2019

Manager Influence on training

SAP qualified