Documentation Specialist

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

This position supports the operational activities of the site through tasks associated with creation and maintenance of quality documentation. These activities are based on written procedural requirements established both locally and at higher corporate authority.

Create, coordinate, implement, and archive Plant Change Orders, Standard Operating Procedures (SOPs), Batch Records (Work Orders), etc. Maintain critical quality documentation related to Change Control, Validation system, including Installation Qualification and Operational Validations, and Engineering Change Requests. Coordinate and implement all policies, procedures, and specifications received from Corporate that are applicable to the Austin Plant. Maintain Documentation administration requirements related to all aspects of record management.

• Review and coordinate the creation, edit, and routing of change orders for new and revised Standard Operating Procedures, Work Instructions, Batch Records, etc. as requested for the Austin and Round Rock manufacturing sites.
• Create and issue Batch Record packages, using the Document Management System (DMS), to all appropriate operational areas within the Austin and Round Rock manufacturing sites, based on the plant manufacturing schedule(s).

Knowledge & Skills

• Demonstrated skills on a personal computer using word processing, spreadsheet, and/or
• database software as well as standard business communication tools such as Microsoft
• Must be able to prioritize and manage a high volume of complex activities; priorities may

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• 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.