Quality Documentation Specialist (GMP/Change Control)

Unicon Pharma Inc; Austin (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Unicon Pharma Inc. in Austin, TX is seeking a Quality Documentation Specialist to support site operations by creating and maintaining quality documents according to local and corporate procedures.

You will create, coordinate, implement, and archive Change Orders, SOPs, Batch Records, and related documents, maintain change control and validation records, and ensure proper routing and archival via the Document Management System (DMS) for both Austin and Round Rock sites.

Qualifications

• Must be at least 18 years old.
• Associates degree from an accredited college or university is required.
• 1 year of applicable experience is required.
• In lieu of the Associates degree requirement above, a High School Diploma with 3 or more years of experience in a quality or production related role in a GMP environment is required.

Responsibilities

• Create, coordinate, implement, and archive change orders for SOPs, work instructions, batch records, etc.
• Maintain critical quality documentation related to change control, validation system, IQ/OQ, and ECN.
• Review and route change orders for new and revised SOPs and batch records.
• Create and issue Batch Record packages via the Document Management System for the Austin and Round Rock sites.

Skills

Word processing

Spreadsheets

Database software

Microsoft Office

Education

Associates degree

High School Diploma with 3+ years GMP experience

Job description

Unicon Pharma Inc. in Austin, TX is seeking a Quality Documentation Specialist to support site operations by creating and maintaining quality documents according to local and corporate procedures.

You will create, coordinate, implement, and archive Change Orders, SOPs, Batch Records, and related documents, maintain change control and validation records, and ensure proper routing and archival via the Document Management System (DMS) for both Austin and Round Rock sites.