At present, Quality & Compliance is accepting applications for the position of cGMP Associate. If you have the required qualifications and would like to join a leading cGMP consultancy, please submit your resume along with a short covering letter to Graham Mills:
Fax: 905-542-7981
Mail: 66 Witherspoon Street, Suite 1400
Princeton, NJ 08542
E-mail: gmills@qualityandcompliance.com
Only candidates considered for an interview will be contacted.
Position
cGMP Associate
Duties
Technical writing:
Produce SOPs
cGMP training:
Facilitate cGMP training sessions
cGMP auditing:
Perform cGMP audits of:
- Full U.S. cGMPs
- Full Canadian GMPs
- Importer/distributors
- Laboratories
- Packaging components
Quality Control Officer* duties:
Organize technical information from manufacturers
Review regulatory commitment documents
Review stability programs
Evaluate warehouse setups
Train warehouse personnel on cGMPs
Determine analytical requirements
Review and release product on an ongoing basis
Perform annual self-inspection for importers
*to be performed according to established procedures
Expectations
The employee is expected to have the following:
The ability to work independently
The ability to work as part of a project implementation team
Self-motivation
Project-oriented skills, with the ability to work on more than one project at a time
Strong organizational skills
Excellent attention to detail
The ability to adapt personality style to fit a variety of situations
Minimum Qualifications
Education:
Bachelor of Science degree in chemistry, microbiology, biology, pharmacy or related science, or equivalent industry experience
Experience:
3 years in the pharmaceutical industry in a quality assurance or quality control role
Computer skills:
Basic to intermediate skills in programs used by Q&C:
- Word2000
- Excel
- PowerPoint
- Visio
- MS Outlook (or equivalent)
Willingness and ability to learn new programs