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RONALD J.

KARCHENES
1-781-356-8461 rkbb3548@westpost.net
79 Hayward St., Braintree, MA 02184
SUCCESSFUL QUALITY ASSURANCE MANAGEMENT PROFESSIONAL
Quality Assurance Professional with 15+ years holding positions of increasing re
sponsibility. Record of success in directing corporate GMP, GLP, and GCP progra
ms for successful companies (commercial products, contract drug synthesis, and c
linical supply manufacturer). Credited with developing and implementing process
es & procedures aimed at fueling exceptional productivity and efficiently remedy
ing production problems. Committed to building QA programs from ground up.
Developed first Good Laboratory Practices program for Eisai Research Institute w
here none had previously existed. Recruited and trained GLP QA Specialist for r
eview of final reports, statistical and data review as well as performance of in
ternal audits.
Reviewed GCP protocols and audited clinical sites for GCP compliance, review of
the IRB, inclusion / exclusion, case report form, etc.
Responsible for GMP and GLP internal audits from drug development to drug produc
t. Worked with audited departments to correct deficiencies found.
Developed CAPA programs to ensure that corrective actions for Deviations, Audits
, Investigations and batch record observations were completed in a timely manner
. This resulted in a 25% drop in failures, audit observations and raised the int
egrity and quality of the products produced. This also helped save the company o
bservations by regulatory inspectors.
Developed Vendor Qualification Programs and Quality Agreements to ensure that CM
Os and CROs met cGMP and GLP standards resulting in better control of the produc
ts and data produced.
Adapted GLP review of data to clinical study reports to ensure the integrity and
quality of the data was as high as GLP reports.
Oversaw software validation of laboratory instruments and electronic document ma
nagement system.
Optimized operational productivity, accuracy and efficiency by spearheading fail
ure investigations, OOS investigations and Deviations.
Developed training methodologies for GMPs and GLPs. This increased personnel un
derstanding of regulations and elevated the quality of GMP products produced and
the quality and integrity of the GLP data generated.
Worked with Manufacturing to develop batch records and reviewed them for complia
nce with regulatory requirements and company policies.
EXPERIENCE
GENZYME
Allston,Massachusetts (March 2010 Present)
Compliance Specialist
Provide GMP review and approval of Cell Culture batch records.
Perform internal audits of Cell Culture manufacturing area and work with departm
ent management to resolve observations.
Review deviations and investigations and track corrective and preventive actions
using Trackwise.
Responsible for conducting GMP training with Cell Culture manufacturing staff.
EISAI RESEARCH INSTITUTE, Andover, Massachusetts (2001 November 20
09)
Multimillion-dollar Drug Company and subsidiary of Eisai Corporate Laboratories
Japan.
Quality Assurance Manager (2005 to November 2009)
Provided effective leadership for all operations pertaining to Good Manufacturin
g Practices 21 CFR Part 210, and 211, ICH Q7A and Good Laboratory Practices 21 C
FR Part 58.
Coordinated Active Pharmaceutical Ingredients production compliance with federal
regulations for Phase I and Phase II clinical trials/toxicology studies for IND
submissions.
Teamed with Production, Analysis and Quality Control to resolve issues with out-
of-specification investigations and failures.
Oversaw and developed QA staff consisting of a GLP Specialist, GMP Specialist, V
alidation Engineer and a Document Control Coordinator.
Hosted corporate audits from our Japan colleagues twice a year. Was responsible
for audit observation responses.
Oversaw all elements of the companies GLP compliance program for Bio-Analytical
Laboratory. This includes:
Critical Phase audits and laboratory facility audits.
Inspection of final report.
Inspection and sign off of QA Statement and GLP Compliance Statement.
Inspection of raw data.
Responsible for ensuring all GLP training.
Responsible for auditing of all GLP CROs.
Responsible for writing and approving all GLP compliance SOPs and other regulato
ry documents.
Responsible for all aspects of the companies GMP program. This includes:
Review and approval of Master Batch records.
Review and sign off of executed batch records.
Review, release of raw materials, intermediate and final products.
Conduct internal audits of all GMP areas.
Responsible for auditing of all GMP vendors and contract CROs.
Responsible for writing and approving all GMP compliance SOPs and other regulato
ry documents.
Managed Change Control Committee.
Member of several international project teams.
Member of regulatory audit teams.

Senior Quality Assurance Specialist (2003 to 2005)


Spearheaded recruitment/acquisition of QA specialist to focus exclusively on GLP
implementation and audit operations. Therefore freeing my time to build the GM
P systems.
Devised successful training program for GLP staff enabling participants to condu
ct higher-quality studies, thereby elevating the data integrity of final study r
eports.
Audited clinical sites to ensure compliance with GCP protocols, review of the IR
B, inclusion / exclusion, case report form, etc.
Conducted both GLP and GMP internal audits according to established schedules.
Quality Assurance Specialist (2001 to 2003)
Skillfully directed all Good Laboratory Practices processes for company.
Thorough review of batch records and GLP records and implementation of staff tra
ining programs, dramatically improved batch record accuracy.
Developed updated training and staff development processes to guarantee full com
pliance with company and federal guidelines.
Orchestrated and conducted audits for all contract research and manufacturing or
ganizations and reviewed final reports.
LIFETECNET, Northborough, Massachusetts (2000 2001)
Online inventory system developer for the pharmaceutical industry.
Document Manager
Delivered standard operating practice procedures and documentation for software
development for pharmaceutical industry material management.
Implemented Good Manufacturing Process strategies to amplify business operations
.
Created training materials and strategies to elevate performance of personnel.
Devised effective software testing plans and crafted all system documentation.
Early Career:
Copley Pharmaceuticals, Internal Auditor 1998 to 2000
Audited all aspects of generic pharmaceutical manufacturing.
Worked with vendor that supplied squeeze bottles for enema product. With my hel
p bottle defects were significantly reduced and label errors were significantly
reduced.
Serono, QA Supervisor 1996 to 1998
Supervised four-person QA department. Batch record review and approval, release
of Human Growth Hormone product. Conducted GMP training. Wrote all compliance
related SOPs. Reviewed & approved all other SOPs.
Pharm-Eco Laboratories, QA Supervisor 1994 to 1996
Created QA department. Developed and implemented SOPs and Batch records for cont
ract API manufacturing. Responsible for hosting customer audits.
Telor Ophthalmic Pharmaceuticals, QA Supervisor 1994
Virtual Company. Managed compliance of raw material suppliers, CMOs and CROs as
well as GCP clinical sites.
Genzyme, QA Associate 1992 to 1994
Managed Raw material review and release and batch review and release of 1st gene
ration Ceredase product.
Charles River Laboratories, QA Associate 1989 to 1992
Batch review and release, host of customer visits, GMP training, for contract mo
noclonal antibody manufacturing.
EDUCATION
Bachelor of Arts, Biology, Boston University, Boston, Massachusetts
GMP & GLP Courses, Center for Professional Advancement
Professional Affiliations: Society of Quality Assurance