With work experience over 20 years, Jim Spencer is currently working at Pharmaceutical Associates, Inc as a Senior Director Validation. Jim received his education from 1973 to 1977 at the Massachusetts College of Pharmacy and Health Sciences. Jim Spencer is located in Matthews, North Carolina. To contact with Jim, you can search for their phone number or e-mail address or get further info by requesting access to this person's additional details on this webpage.
Name variants:
James Spencer
Last updated May 26, 2024
Contact Information
Last Update
Jul 8, 2022
Location
Matthews, NC
Workplace
Senior Director Validation
Greenville, SC
Industry
Pharmaceuticals
Colleagues
Work History
Senior Director Validation
Greenville, South Carolina Area
Lead the Validation Department in performing all the tasks related to validation of processes, equipment, packaging and computer validation in a liquids production facility
from Jan 2013
Contract Project Manager
Fort Washington, PA
Project Management for Consent Decree team in Validation. (Process, Cleaning, Packaging)
Jan 2012 — Dec 2012
Senior Consultant
Wilson, NC
Oversee the Technical Transfer of selected solid dosage products from a site in another location to the Wilson site.
Oct 2011 — Dec 2011
Senior Consultant
I reviewed the product information for various products including validation documents, annual reports and aother related documents to determine if a trend existed which might mean product n...
2011 — 2011
Project Manager
Boston, MA
Acting as a project Manager with some QSE teams to correct regulatory issues
Jun 2010 — Jul 2011
Project Management Planner
Created the start-up plans for a new aseptic filling and packaging line. I also created project plans on the development of drug products for the Product Development group.
2009 — 2009
Valadation Lead
lead the Validation efforts on equipment and process for the start-up of a vaccine syringe filling and inspection line.
2007 — 2008
Sub Contractor
I worked as an interim production manager for a pharmaceutical production facility. I designed a program for the handling of controlled substances then acted as the trainer. I implemented ...
2007 — 2008
Senior Consultant
Audited executed validation protocols for completeness and possible problems that might cause regulatory concern should these protocols be check by regulators. I also wrote and oversaw the ...
2003 — 2005
Vice President Manufacturing
Aided in the design of a new manufacturing facility.
Directed all manufacturing and packaging operations at the facility.
Managed contracted packaging operations.
Served on MRP implematati...
Oct 1998 — Apr 2000
Plant Manager
Managed all aspects of plant operation in the manufacture of generic pharmaceuticals.
Dec 1992 — Mar 1998
Materials Manager
I over saw the purchasing of raw materials and other components for the manufacture of a vaccine product. I coordinated the contract filling and packaging of the vaccine products. Coordina...
1988 — 1989
Department Head
Henrietta, NY
I lead a team in the production of of liquid and solid dosage pharmaceutical products as well as a specialized process for the production of some product intermediates. Oversaw the start-up...
Mar 1982 — Mar 1988
Education
1968 — 1969
Occupations
Executive
Senior Director
Engineer
Sales Specialist
Equipment Tools Purchasing Agent
Project Manager
Senior Manager
Operations Manager
Department Store Salesperson
Retail Salesperson
Project Managers
Skills
Validation
Gmp
Pharmaceutical Industry
Fda
V&V
Technology Transfer
Change Control
Computer System Validation
21 Cfr Part 11
Quality Assurance
Cleaning Validation
Pharmaceutics
Regulatory Affairs
Capa
Medical Devices
Gxp
Quality System
Sop
Quality Control
Process Engineering
Aseptic Processing
Manufacturing
Biopharmaceuticals
Biotechnology
Quality Auditing
Regulatory Submissions
Quality Management
Glp
Vaccines
Lims
Gamp
Regulatory Requirements
Gcp
Analytical Chemistry
Iso 13485
Hplc
Clinical Trials
Lifesciences
Protocol
Clinical Data Management
Process Validation
Clinical Development
Trackwise
Cro
R&D
Document Management
Process Simulation
Drug Development
Pharmacovigilance
Cgmp
FAQs about Jim Spencer
What is the profession of Jim Spencer?
This professional's job is Cqv Engineer
What jobs is Jim a professional at?
Jim Spencer is a professional such jobs as Executive and Senior Director.
Where is Jim Spencer currently located?
The professional is currently located in Matthews, North Carolina.
Where did Jim Spencer work?
This person worked at Pharmaceutical Associates, Inc., McNeil Consumer Healthcare.
Where has Jim Spencer studied?
Jim studied at the Massachusetts College of Pharmacy and Health Sciences from 1973 to 1977.
Are there any professional industries Jim Spencer is connected to?
Jim Spencer works in Pharmaceuticals industry.
Are there any special skills Jim Spencer has?
This professional has the following skills: Validation, Gmp, Pharmaceutical Industry, Fda, V&V, Technology Transfer, Change Control, Computer System Validation, 21 Cfr Part 11, and Quality Assurance.