COLIN P. DONEGAN
** ****** **** *******, ** ***85
Home Phone: 973-***-**** Cell Phone: 973-***-**** Email: ********@*********.***
OBJECTIVE
To acquire a supervisory or managerial level position in a company that could best use my
experience and expertise in Pharmaceutical industry or similar manufacturing environment.
PROFESSIONAL EXPERIENCE
ABBOTT LABS (FORMERLY KOS) May 2006-December 2008
Shift Manager, Production
Supervision of Granulation, Compression, and Coating departments manufacturing
process insuring cGMP, Standard Operating Procedures and company policies
compliance.
Authoring and follow up of deviations in Trackwise computer system.
Timely review of Compression and Coating batch records to expedite batch release.
Production scheduling and execution
Recognition for work performance by achievement of 3 (Three) Abbott Silver awards
ABBOTT LABORATORIES 2004-2006
Manufacturing Supervisor
Direct Supervision of Central Weighing and Granulation sections of the Solid Dosage
Department of Manufacturing and Chemical (API Manufacturing) Department to insure
all government agency regulations and company policies are followed.
No FDA observations during audit in 2005.
Responsible for access to the narcotics vault in handling and reconciliation of CIII and
CII narcotics.
Increase batch production in Chemical Department from 58 in 2004 to 73 batches in 2005
with less overtime.
NOVARTIS PHARMACEUTICALS (Formerly Sandoz Pharmaceuticals) 2002 - 2003
Manufacturing Project Coordinator
Assisted Manufacturing Engineers on cleaning and equipment validation projects
Cleaning Validation representative for Manufacturing, attending monthly meeting and
responsible for monitoring and timelines for Cleaning Validation activities in
Manufacturing.
Responsible for documentation of Change Control documents and updating of SOP’s
effected by changes.
Manufacturing Supervisor (1997-2002)
Supervision of Pharmacy (Dispensing) Department in a team environment for all (3)
three shifts.
Responsible for cGMP/SOP and company policy compliance.
SOP writing and revisions
Review of completed batch records and new batch record revisions.
Responsible for warehousing and segregation of materials and insuring only QC/QA
released raw materials are used using FIFO method.
Responsible for AWDS (Automated Weigh and Dispense System) at administrative level
in Bill of Materials maintenance and troubleshooting problems.
SANDOZ PHARMACEUTICALS (1987 – 1997)
Foreperson
Direct supervision of the manufacturing processes on the production floor in the Central
Weighing and Granulation Departments of Manufacturing.
Performed all administrative duties in BPCS inventory system in issuing raw materials
and reviewing completed batch records.
Assumed position of acting manager to Associate Director of Solids Department during
his absence due to company merger. I was responsible for all departments (Central
Weighing, Granulation, Compression, Encapsulation and Coating) in Solids Department.
Sandoz Technical Operations 1987 Excellence Award.
Utility/Pharmaceutical Operator (1983-1987)
Experienced in wet granulation, dry blending, fluid bed and oven drying, and particle
sizing using PK blender, Collette gral, Stokes tornado mill, Russell sieve, Frewitt
oscillator and other production equipment.
Conformance to GMP and SOP requirements by following batch records accurately in
Central Weighing and Granulation processing.
Rotated into Central Weighing functions of verifying released status of raw material,
dispensing and accurate weighing to batch record specifications.
Material Handler (1979-1983)
Supplied Packaging Department production lines with semi-finished tablets/capsules and
packaging materials needed and adhered to GMP and SOP compliance.
Mailroom Clerk (1979)
Responsible for sorting and distributing departmental and external mail.
EDUCATION
High School Diploma, Morris Knolls High School, Denville, New Jersey 1976
Supervisory Management Development Course, Rutgers University Center for
Management Development 1987