Quality Assurance Documentation Associate


Job ID 17-00256

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

SUMMARY:
This position is primarily responsible for preparation/maintenance of master batch records, certificate of analysis, in-process specification, finished bulk product specification and packaging specification.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Ensures compliance with cGMP, Company SOPs and FDA requirements during all phase of operations.
Prepares and maintains master batch record.
Prepares and maintains in-process specification, finished bulk product specification and packaging specification.
Prepares and maintains finished product certificate of analysis.
Issuance of packaging specification.
Responsible for finished product packaged record and maintain log book.
Organizes and ensures accurate and reliable filing systems for all paper-based GMP Documents.
Performs other duties as assigned.



Qualifications

EDUCATIONAL QUALIFICATION:
Four year college degree or equivalent; and one to two years related experience and/or training; or equivalent combination of education and experience.