Quality Control Testing

Edward McMillan

P.O. Box ****

Pinehurst, NC ****4

910-***-**** ***********@**********.***

PROFESSIONAL EXPERIENCE

Biomerieux, Durham, NC

Quality Control Analyst(Microbiology) (May 2013-August 2013)

2013

. Duties performed:

. Bioburden Testing

. Gram Staining

. Subculturing of Organisms

. Microbial Identification (Vitek 2)

. Water Testing (Microbial)

. Water Collection

. Environmental Monitoring of Production Facilities

. EM included viable air and surface sampling

. Plate Reading

GlaxoSmithKline, Zebulon, NC

Assistant Scientist (QC Microbiology) (Feb. 2012 - June 2012)

2012

. Environmental Monitoring (Solid Dose Production Facilities)

. Purified Water Collection.

. Microbial Testing of Purified Water.

. Plate Reading and Excursion Determination.

. Compressed Air Sampling (Viable and Non-Viable)

. TOC Testing.

. Conductivity Testing.

. Swab Sampling of Production Equipment.

Merck, Sharpe and Dohme Corp., Durham, NC

2010

Environmental Monitoring Technician (VBF Quality) (Aug. 2010 - Nov. 2011)

. Support Facility Qualifications in the Varicella Bulk Facility

. Duties include the following:

. Clean Steam Sampling.

. WFI Sampling.

. Clean Dry Air Monitoring.

. Perform Personnel Gowning Qualifications.

. Non-Viable Monitoring of Clean Rooms.

. Surface Monitoring of Clean Rooms.

. Compressed Gas Monitoring.

. Per Process Monitoring In Virus I and Virus II Production Areas

. Routine EM and Water Collection.

Edward McMillan 910-***-****

Page 2

Schering-Plough (Organon Teknika), Durham, NC

2009

Quality Control Microbiologist Scientist I (Sept. 2009 - Dec. 2009)

. Performed residual moisture determination testing.

. Used LOD (loss on drying) chamber.

. Microbiological and endotoxin analysis of process waters.

. Performing validation testing of lyophilized samples.

Wyeth Vaccines, Sanford, NC

1996 - 2008

Quality Control Microbiologist Scientist II (2004 - 2008)

. Revised environmental monitoring maps and water sampling maps for all

manufacturing areas.

. Generated monthly training reports for analysts and managers with 97%

training efficiency.

. Assisted analysts with training gaps (achieving 100%).

. Performed swab sampling and testing of manufacturing environment.

Wyeth Vaccines, Sanford, NC (Continued)

. Document Sponsor (revised departmental SOP's).

. Utilized LIMS software for all data entry.

. Primary reviewer of aseptic field data (met or exceeded metric standard).

. Create SOP's for Microbiology EM group.

. Performed Kinetic Turbidimetric Endotoxin Testing.

. Performed Risk Analysis for disinfectant use in Manufacturing Facility.

. Initiated reports for investigations pertaining to lab deviations.

Quality Control Microbiologist Scientist I (1999 - 2004)

. Environmental monitoring of all production areas.

. Facility WFI, Clean Steam and RO Sample collection

. Testing of water samples for (TCFU, LAL, & Particulates).

. Environmental Monitoring of Aseptic Fills (Facility wide).

. Bioburden testing.

. Compressed Air Pharmaceutical (CAP) air testing.

. Initiated investigations.

. Depyrogenation of equipment.

. Sterilization of equipment.

. Expert on The Job Training (EOJT).

. Use of biological indicators for sterility testing.

Manufacturing Associate II (1998 - 1999)

. Activation and processing of seven serotypes of the pneumococcal Vaccine

Prevnar.

. Conjugation, final diafiltration, and sterile filling associated with all

seven serotypes of the above -mentioned vaccine.

Manufacturing Associates I (1996 - 1998)

. Activation of Hibtiter Polysaccharide

. Lyophilization of Haemophilus B Oligosaccharide (HBO) Hibtiter.

. Final Diafiltration and Sterile Fill Operations.

Edward McMillan 910-***-****

Page 3

EDUCATION

BA, Biology, University of North Carolina at Chapel Hill

RECOGNITION

. Expert OJT Workshop

. Quality Award (Job Performance)

. Certificate of Continuing Education

(Management & Leadership Skills)

. Microbiologic Staining Techniques

(Wake Technical Community College)

Contact this candidate