Sr. Manager SVP Modernization @ Hospira, a Pfizer Company
Manager, Quality Assurance @ Hospira
Sr. Manufacturing Quality Supervisor @ Hospira
Sr. Manager SVP Modernization @ Provides Quality oversight for the modernization project on-site. Drives and oversees the execution of functional plans, identifies and resolves functional issues and escalates by exception. Responsible for all Quality decisions and assessment of compliance impact of project activities throughout the design/construction/procurement and validation process. From March 2015 to Present (10 months) Manager,
Sr. Manager SVP Modernization @ Provides Quality oversight for the modernization project on-site. Drives and oversees the execution of functional plans, identifies and resolves functional issues and escalates by exception. Responsible for all Quality decisions and assessment of compliance impact of project activities throughout the design/construction/procurement and validation process. From March 2015 to Present (10 months) Manager, Quality Assurance @ From June 2013 to Present (2 years 7 months) Rocky Mount, North Carolina AreaSr. Manufacturing Quality Supervisor @ From June 2012 to June 2013 (1 year 1 month) Quality Compliance Supervisor @ Responsible for reviewing, editing, and the disposition of deviation reports. Perform review and approval of change control activities. Responsible for reviewing and approving of SOP’s, Process Validation Protocols, Validation Reports, Addendums, Cleaning and Equipment Validation Protocols and Reports and Process Run Reports which supports manufacturing campaigns. Perform and verify product changeover procedures for manufacturing on an as needed basis. Participate within the on-going cGMP training of manufacturing employees. Train and mentor new QA Compliance employees. Assist with the review of other GMP documentation (test methods, MBR’s (Manufacturing Batch Records), sanitization forms, etc). Provide monthly summary reports to customers as well as management on status of lot dispositions. From September 2005 to June 2012 (6 years 10 months) Quality Coordinator @ Responsible for maintaining employee-training files. Maintain departmental standard operating procedures via Metaphase. Involved in the development and revision of new standard operating procedures. Coordinates interviews for all new employees within the Quality Formulation/Finishing department. Schedule and coordinate training activities for QA Inspectors in support of aseptic filling, capping, lyophilization, label issuances and final container packaging processes. Conduct departmental investigations for discrepant material, deviation notices and alert/action reports. Perform detailed investigations for production lot issues. Support numerous internal, as well as, regulatory site investigations. Knowledge of the requirements of the FDA as well as a thorough understanding of cGMP. Maintain and track the inspection of retention samples and destruction of rejected materials. Involved with the implementation of results resulting from CAPA investigations. Perform JDE transactions. Maintain training files using Isotrain. From May 2001 to September 2005 (4 years 5 months) Senior QA Fill/Finish Inspector @ Responsible for the inspection activities in the manufacturing process; including Aseptic Filling, Over capping, Label Store and Packaging areas, tagging and un tagging of discrepant material(s), label accountability and control and release of packaged product, inspection of product retention samples. Perform JDE transactions.
Involved in the development and revision of standard operation procedures and training of new employees as well as employee training files.
Perform exception investigations and special projects as necessary.
Review in-process inspection job orders. Review temperature and humidity charts and logs. Perform action level investigations. Initiate ORDO for disposition of rejected material. Perform detailed investigations for production lot issues for aseptic filling, over capping and packaging. Perform the sampling of incoming chemicals to meet specific needs. Knowledgeable in cGMP, GDP, aseptic techniques, and GLP. From May 2001 to September 2005 (4 years 5 months)
BS, English Literature/Business Management @ The University of Texas at El Paso From 1989 to 1993 Fred Billingsley is skilled in: Change Control, CAPA, Trackwise, Validation, GMP, Sop, Aseptic Processing, LIMS, Sterilization, FDA GMP, 21 CFR, 21 CFR Part 11, Analytical Chemistry, Aseptic Technique, Biopharmaceuticals
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