JOB SUMMARY: The QA Specialist, (Document Reviewer) is responsible for the review of cGMP records.

JOB RESPONSIBILITIES:
1. Review of cGMP documentation associated with batch records, protocols (method qualification/validation, process validation, cleaning qualification/validation, stability studies, installation operation and performance qualification, etc.)
2. Review of records associated with QC Microbiology, QC Analytical Chemistry, equipment, facilities, utilities, environmental monitoring, etc.

MINIMUM REQUIREMENTS FOR EDUCATION, TRAINING AND EXPERIENCE:

1. Must be skilled in the use of computers and proficient is in the use of word processors and spreadsheets.
2. Must have strong organizational skills and ability to prioritize and multi-task.
3. Bachelors Degree
4. Minimum of 2 years industry experience in a GMP or GLP environment.
5. Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600)
6. Knowledgeable in ISO 9001 and 13485 a plus.