Judge Technical Staffing

Key Responsibilities:

Responsible for the supervision of Document Specialists.  Performs quality review of completed manufacturing documentation, internal quality audits, Deviations, Stability data, Validation protocols, etc.  Ensures that all documents are maintained and issued in compliance with all prevailing cGMP regulations, and ensures the compliance of all Quality Systems.

Specific Duties in a cGMP environment:

Keep records of documents requested, issued, filed, or removed, using logbooks and/or computers according to written procedures.

Receive and distribute controlled documents to appropriate individuals and/or departments according to written procedures.

Assigns production lot numbers, document control numbers, color codes etc. according to written procedures.

Maintains signature log, training records, employee orientation checklists, etc. as required by written procedures.

Assist in review and completion of Deviations, CAPAs, Investigations, etc. as required.

Assist in performing internal audits if needed and providing documentation.

Write and Revise SOPs.

Requirements:

Must have a BS and at least three to four years cGMP experience in the pharmaceutical, biotechnology or medical device industry. CFR 210 and 211 cGMPs, CFR 600 and 610. Performs functions consistent with a minimum of 3-4 years experience in FDA Current Good Manufacturing Practices.

Quality Assurance, Internal Auditing, SOP revision, CAPA

Please contact:

For immediate and confidential consideration, please send a copy of your resume to ssmith@judge.com

Susan Smith

Scientific/Clinical Recruiter

Fax: 610.784.8201

www.judge.com