• Vienna, VA

Michael Conners

QA Specialist            

Summary

Training Coordinator with extensive experience in learning development and implementation. Proficient in creating e-learning material using Adobe Captivate and managing a learning management system to deliver material to the learner. Detail-oriented approach to training development with consideration of the big picture. Use strong collaboration and customer service skills to deliver learning material that meets the project goal.

Work History

Work History

QA Specialist, QA Compliance

2013 - Present
GlaxoSmithKline

LMS Administrator responsible to create and revise items, curricula, and user accounts. Record learning events, run searches and reports to report training compliance metrics. Review & assist in creation of training presentations, online modules, other training materials Manage and deliver pre-campaign training reviews of Manufacturing training assignments for each campaign run at Rockville Develop and expand the training management strategy of the Quality Control teams

Training Specialist, QA Compliance

2012 - 2013
Human Genome Sciences, Inc.

Perform training needs assessment Administer LMS system with focus on Manufacturing training management Develop administrator user guides for LMS system Author, Review and revise departmental Standard Operating Procedures & Training Plans

Technical Training Specialist, Technical Training

2007 - 2012
Human Genome Sciences, Inc.

Conduct training sessions in classroom and hands-on environments. Coordinate and create the following manufacturing training materials: e-learning modules Training Plans for competency courses Training Manuals for manufacturing processes and equipment Manufacturing New Hire Training 4-week program: Generate program schedule & coordinate cross-functional team participation Deliver competency training courses & sessions on a variety of cGMP and Bio-manufacturing topics Coordinator for projects that involve multiple building and clear communication to all involved parties on status and next steps. Communicate project status and best practice updates to Manufacturing and Quality departments Coordinate and facilitate“ On The Job Trainer Skills” course. Strong attention to detail while writing and reviewing training material, SOP and Batch Record content. Producer,Director, Editor, and Videographer for HGS promotional and technical videos

Manufacturing Associate, Training Operations

2005 - 2007
Human Genome Sciences, Inc.

Initiate a training program for Manufacturing Operations department Develop, build consensus and support new SOP and batch record formats Create Training Manuals for manufacturing equipment Coordinate SOP consolidation project in Manufacturing Operations department

Manufacturing Associate, Clinical Production

2002 - 2005
Human Genome Sciences, Inc.

Involved in producing therapeutic proteins for Phase I/II clinical trials. Operation and maintenance bioreactor skids used in mammalian cell culture process. Work closely with Process Development during tech transfer of each new process. Safety representative for production area and member of Safety Committee.

Manufacturing Associate, Protein Development Novel Protein Fermentation

2001 - 2002
Human Genome Sciences. Inc.

 Operation and maintenance of fermenters. Involved in the planning of new lab area and ordering of new supplies and equipment. Develop and maintain communications with surrounding departments including Purification, Facilities, IT and EH&S.

Manufacturing Associate

1999 - 2001
Pro-Virus, Inc.

Production and development of a live viral bio-therapeutic involved in phase I/II clinical trials. Operation and development of size-exclusion chromatography column use to purify clinical material. Train new Manufacturing Associates on the inoculation, harvest and purification steps of the process.

Lead Production Specialist, Retroviral Vector Production

1996 - 1998
Genetic Therapy, Inc./NOVARTIS PHARMA

Managed all operations within mammalian cell culture aseptic manufacturing cleanroom suite. Maintained cGMP compliance of the cleanroom facility. Investigated and solved problems concerning the production facility and Quality Assurance audits.

Research Associate, Retroviral Vector Production

1994 - 1996
Genetic Therapy, Inc

Produced and developed a new product being manufactured for the treatment of brain tumors in Phase I/II/III clinical trials. Operated under aseptic conditions in the cleanroom and followed detailed standard operating and manufacturing procedures.

Education

Education

B.Sc

1994
Salisbury State University

B.S., Majoring in Biology with Minors in Chemistry and Marketing Management