Quality Assurance Control
Resume:
Robert R Reen, Jr
* ****** ** **** **. Wilmington, DE
19803
********@*****.***
EXPERIENCE
McNeil Consumer Healthcare, Fort Washington, PA.
Microbiologist
Presently Employed
Environmental Monitoring of laboratory, production areas and packaging lines for viable and non-viable particulates.
Involved in the collection of USP water throughout the manufacturing plant under aseptic technique.
Working extensively with projects involving the startup of the laboratory and new procedures that will ultimately aid
in future production of product.
Involved in the documentation of results and performing trend analysis for all data involving routine water via LIMS.
Aiding in making new procedures more efficient under Good Manufacturing Practices.
A team member involved in building a successful laboratory that will support the manufacturing of Over the Counter
liquid medications.
Working side by side with cleaning validation to ensure that parts were free from contaminants and aided in
developing better sampling techniques.
DepuySynthes, West Chester, PA (Aerotek)
Sterility Assurance Specialist
Carried out dose auditing of medical devices.
Involved in writing up investigations for bioburden and sterility alert and action limits.
Performed duties under AAMI and FDA guidelines.
Worked extensively correcting observations from audits.
Dealt with reviewing batch records and the release of sterile medical devices.
Carried out investigations with recalls of devices and customer complaints.
GlaxoSmithKline, Conshohocken, PA. (Yoh)
Quality Control Microbiologist
Carried out the initiation, writing, and the corrective action associated with deviations.
Performed bioburden testing of raw materials, WFI samples and in-process manufactured materials.
Performed LAL endotoxin testing of WFI and clean steam samples with LONZA KQCL.
Carried out identification of microbial organisms via gram stain and riboprinter.
Worked with colleagues on trend analysis of environmental monitoring samples.
Created new SOP’s related to daily procedures with lab assessments/deviations.
Trained new and current employees with laboratory procedures and data management within LIMS.
Conducted the review of data from HPLC testing.
Charles River Laboratories, Malvern, PA. (Aerotek)
Microbiology Technician
Developed new methods to analyze samples deemed unsuitable for testing.
Observed, inspected, analyzed and interpreted basic laboratory experiments.
Performed laboratory activities including media preparation, laboratory maintenance/monitoring, microscopy, and
the practice of aseptic technique working within a biological safety cabinet.
Performed assays such as sterility testing by both the pour plate and membrane filtration methods, verified and tested
for total aerobic bacterial count.
Detected phage in sample material by performing both an induction and plaque assay.
Performed microbial identification, and testing for the presence of mycoplasma in sample material, including testing
of the sample for inhibitory factors.
Documented all activities performed in notebooks and test batch records in accordance with the current Good
Manufacturing Practices.
Performed testing of raw materials using HPLC and carried out the review of data with clients.
Carried out the initiation, writing, and the corrective action with deviations.
EDUCATION
Bachelor of Science in Biological Sciences
Neumann University, Aston PA
Major: Biological Sciences Minor: Organic Chemistry
References:
Justin Riddell (GSK)
Microbiology Supervisor
******.*.*******@***.***
Leroy Clark (Medimmune)
Quality Assurance Supervisor
Darryl Browne (Medimmune)
Manufacturing Supervisor
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