1. MICHAEL F. DITTMER
159 Hiawatha Blvd.
Oakland N.J. 07436
201-405-0950(H) 845-602-3142(W) 845-521-1247(C)
OBJECTIVE: To obtain a challenging position where I can utilize, challenge and
expand my skills as an Quality Assurance Specialist.
EXPERIENCE:
2010-Present Pfizer Pearl River, New York
Quality Assurance Specialist
• Supervise a staff of three hourly employees
• Facilitate shift huddles for other departments
• Enforce GMP compliance/adherence to SOPs, proper notebook
documentation, and proper training documentation. Conduct GMP audits.
• Manage Quarantine Area and conduct RGM investigations for both Vaccines
and Pharmaceutical divisions.
• Manage Quarantine Area and conduct RGM investigations for both Vaccines
and Pharmaceutical divisions.
• Work effectively as a support group for Stability and Shipping departments.
Work effectively with Maintenance group.
• Manage and maintain numerous Chillrooms, Freezers, Incubators,
Refrigerators and their monitoring devices. Responsible for safe and efficient
relocation of materials.
• Co-Author of the PARE plan (Emergency Relocation Procedure)
• Manage and Maintain Retention/Reserve program for Vaccine group,
External Supply group and assist with Pharmaceutical group.
• Write and revise Standard Operating Procedures (SOPs).
• Initiate and investigate deviation reports (MIRs).
• Conduct annual product inventory (APQR).
• Responsible for various computer system entries that would include QTS,
SAP, KRONOS, EAMS, LACES/LIMS, ACCESS and PDOCS.
2002-2010 WYETH BIOTECH Pearl River, New York
Supervisor/Fill-Finish QA
• Supervise a staff of one weekly and two hourly employees. Conduct monthly
safety meetings and SOP training.
• Enforce GMP compliance/adherence to SOPs, proper notebook
documentation, and proper training documentation. Conduct GMP audits.
• Manage Quarantine Area and conduct RGM investigations for both Vaccines
and Pharmaceutical divisions.
2. • Work effectively as a support group for Stability and Shipping departments.
Work effectively with Maintenance group.
• Manage and maintain numerous Chillrooms, Freezers, Incubators,
Refrigerators and their monitoring devices. Responsible for safe and efficient
relocation of materials.
• Responsible for various computer system entries that would include
Trackwise, SAP, Kronos, GXPharma, MAXIMO, LACES/LIMS, ACCESS and
ISOTRAIN.
• Manage and Maintain retention program for Vaccine group, External Supply
group and assist with Pharmaceutical group.
• Write and revise Standard Operating Procedures (SOPs).
• Initiate and investigate deviation reports (MIRs).
• Conduct annual product inventory (APQR).
• Winner of Best Practice Award (2003) for the P.A.R.E Plan.
1999-2002 WYETH-LEDERLE VACCINES Pearl River, N.Y.
Senior Supervisor/Animal Care
• Supervise a staff of four weeklies and eight hourly people. This would include
animal husbandry, treatments, and observations of animals, hiring and
training of new attendants/technicians and annual retraining of
attendants/technicians in place.
• Enforce GMP compliance/adherence to S.O.P.s, proper notebook
documentation, proper training documentation and preventive maintenance
orders (PMO) for laboratory equipment. Conduct GMP audits and remedy all
violations.
• Enforce safety compliance, personnel safety, building safety and regulate
biohazard waste disposal. Responsible for maintaining safe work
environment, performs safety audits, and remedy all violations.
• Responsible for safe working environment.
• Write and revise Standard Operating Procedures (S.O.P.s) and Job Hazard
Analysis (J.H.A.s).
• Received AAALAC accreditation for vivarium. First time applicant. Started up
Bldg. in 1999 and received accreditation in November of 2000.
• Responsible for Antisera project. This would include documentation and
hands on animal work.
• Started up a new barrier suite for research & development work. Maintain
compliance.
1993-1999 WYETH-LEDERLE VACCINES Pearl River, N.Y.
Supervisor/Primate Unit and Breeding Colonies
• Supervise and direct Animal Technicians in Primate Unit. This would include
Animal Husbandry, treatments, and observation of Primates, surgical skills,
hiring and training of new Technicians and annual retraining of Technicians in
place. Supervise three (3) breeding colonies located in Louisiana, Texas and
St. Kitts. Track each Primate (Rhesus, African Green) for duration of life.
Responsible for each Primate to be tested for Filovirus, FV2, FV1, SV40, SIV,
3. TB, MEASLES, HERPES B and CMV before entry into New York. Arrange and
schedule flights. Supply and maintain Pharmacy (controlled substances).
• Enforce GMP compliance/adherence to S.O.P.s, proper notebook
documentation, proper training documentation and preventive maintenance
orders (PMO) for laboratory equipment. Conduct GMP audits and remedy all
violations.
• Enforce safety compliance, personnel safety, building safety and regulate
biohazard waste disposal. Responsible for maintaining safe work
environment, performs safety audits, and remedy all violations.
• Write and revise Standard Operating Procedures (S.O.P.s), Job Hazard
Analysis(J.H.A.s) and training documentation forms.
1989-1993 LEDERLE-PRAXIS Pearl River, N.Y.
Scientific Assistant
• Observation and husbandry of Mice, Guinea Pigs, Sheep, Goats, Rabbits and
Primates. Document all observations in proper notebooks.
• Gross necropsy of animals including extraction of Brain and Spinal Cord from
Primates.
• Responsible for safe working environment.
• Write and revise Standard Operating Procedures (S.O.P.s) and Job Hazard
Analysis (J.H.A.s)
• Started up alternative testing site at University of Southwest Louisiana.
Nominated and won a special recognition award.
1984.1989 MEDICAL RESEARCH: DIVISION OF AMERICAN CYANAMID
Pearl River, N.Y.
Animal Attendant and Technician
• Observation and husbandry of Mice, Rats, Guinea Pigs, Canines, Rabbits and
Primates. This would include care, sexing, handling and restraint and various
bleeding techniques. Techniques include Intravenous,Intramuscular,
Intraperitoneal, Intracardiac and Subcutaneous.
EDUCATION:
1996-1997 Chairman of EXCELL committee (WLVP)
1995-1996 Institute of Laboratory Animal Management (ILAM)
1996 Elected President of Class (ILAM).
1993 Laboratory Animal Technician (LAT AALAS)
1980 Clarkstown North High School New City, N.Y.
HOBBIES:
Family, Martial Arts, College Basketball Official