Key Catalent Facts
- We serve 49 of the top 50 pharmaceutical companies and 36 of the top 50 biotechnology companies.
- We support 80 percent of the top 200 selling drug compounds.
- We produce nearly 90 percent of the prescription drug products available in the U.S. market in the softgel dosage form.
- We make or package 100 billion doses per year.
- We hold some 1,500 patents and patent applications.
Job Summary
- Location
- Winchester, KY 40391
- Job Type
- Full Time
- Job Category
- Quality Assurance/Safety
- Occupations
- Production Quality Assurance
- Industries
- Biotechnology/Pharmaceuticals
- Work Experience
- 2+ to 5 Years
- Career Level
- Experienced (Non-Manager)
- Education Level
- Bachelor's Degree
Contact Info
- Job Reference Code
- 129
Our full name is Catalent Pharma Solutions, but you know us as Catalent.
Catalent Pharma Solutions is a leading provider of advanced technologies and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health care companies worldwide. Catalent was created in April 2007 when an affiliate of The Blackstone Group acquired the Pharmaceutical Technologies and Services segment of Cardinal Health.
Catalent is the name we created to combine the ideas embodied in the words "catalyst" and "talent." Our name and logo signify empowerment, progress and our ability to transform customer ideas into viable, high-qualitypharmaceutical products. We are committed to using our experience, expertise and innovation to develop and deliver creative, dependable solutions that meet our customers' needs and enable them to succeed in the marketplace.
We are headquartered in Somerset, New Jersey, and employ approximately 9,100 at more than 30 facilities worldwide.
Catalent. Reliable Solutions. Inspired Results.
QA, cGMP Compliance Auditor
Job Description
Catalent Pharma Solutions is recruiting for a QA cGMP Compliance Auditor position based in Winchester, KY.
The QA cGMP Compliance Auditor is responsible for supporting the review and auditing of Winchester validation and microbiology documents, as well as playing a key role in all Winchester customer/agency audits.
The primary responsibilities of the QA cGMP Compliance Auditor are:
1. Participate in regulatory agency audits of the facility and systems.
2. Participate in customer audits of the facility and systems.
3. Assist during internal audits of the facility
4. Assist in the Supplier audit program.
5. Communicate with applicable departments to obtain responses to audits.
6. Compile and distribute audit responses into report format.
7. Follow-up with appropriate department representatives to ensure corrective actions have been
8. incorporated within the committed time frame.
9. Review facility records as a representative of the Quality Assurance unit.
10. Investigate facility records as necessary and report findings to top Quality heads.
11. Assist the QA GMP Compliance Supervisor in the review, revision, training and implementation of
SOPs.
12. Assist the QA GMP Compliance Supervisor with other Quality Assurance duties as assigned.
Job Requirements:
A Bachelor's Degree in a scientific discipline is required.
A minimum of 2 years of experience in a quality role in the pharmaceutical industry is required.
Experience with Track Wise is preferred.
Experience with cGMP systems is required.
Must be computer literate and detail-oriented.
Excellent written, oral, organizational and interpersonal skills are required.
Up to 10% travel (domestic is required).
A minimum of 2 years of experience in a quality role in the pharmaceutical industry is required.
Experience with Track Wise is preferred.
Experience with cGMP systems is required.
Must be computer literate and detail-oriented.
Excellent written, oral, organizational and interpersonal skills are required.
Up to 10% travel (domestic is required).
This position is not eligible for relocation assistance.
Search Firm Representatives - Please Read Carefully:
Catalent Pharma Solutions is not accepting unsolicited assistance from search firms for this opportunity. Please, no phone calls or e-mails. All resumes submitted by search firms to any employee at Catalent via e-mail, the Internet or in any form and/or method without a valid written search agreement in place for this specific position will be deemed the sole property of Catalent. No fee will be paid in the event the candidate is hired by Catalent as a result of the referral or through other means.
Req. Code : 129
Division/Department : Catalent Pharma Solutions Oral Technologies
Shift/Hours : First Shift (Day)
% of Travel Required : None
Offer Relocation : No
