DEPARTMENT: Quality Control REPORTING TO: Incoming Materials Supervisor, Quality Control SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIY Responsible to be the contact person between QC and QA when writing and finalizing investigative reports and other documents for Quality Control.
Write or revise documents in QC such as; SOPs, CAPAs, Control Specifications, protocols, etc.
Must have experience working in a GMP laboratory environment.
Distributes training forms in Quality Control for newly revised documents.
Interfaces with outside customers regarding documentation changes and updates.
Maintains security of document hard copies and electronic files.
Participates and assists with internal and external audits.
Evaluates document update impact on customer s products.
Assists with departmental training. The duties listed are not all inclusive and additional performance of non-testing tasks may be necessary.
REQUIREMENTS: BS/MS in a scientific field with five or more years GMP experience.
Should have significant experience in writing QC documents and must have a laboratory background.
Excellent computer skills with Microsoft Office, Word, Excel, Access.
Excellent skills for written and oral communication, organization, time management, multi tasking, self initiative worker with attention to details.
Excellent grammar skills are important.
Interacts with all levels of the company.
Ability to work in a fast paced environment while delivering high quality, timely results.
Location/Region: Caldwell, NJ (US)