Documentation Specialist

Job Title : Documentation Technician

Duration : 12 months with possible extension

Location : 3900 Howard Lane, Austin, TX, USA, 78728

Schedule : Second Shift

Job Description:

We’re seeking a detail-oriented Documentation Technician to support quality documentation activities across our Austin and Round Rock manufacturing sites.

Key Responsibilities:

• Create, review, route, implement, and archive SOPs, Batch Records, Work Instructions, and Change Orders.
• Maintain controlled documentation, validation packages, logbooks, and records.
• Support Change Control and Validation documentation processes.
• Coordinate document issuance, tracking, distribution, and records management.
• Perform administrative reviews to ensure compliance with cGMPs and site procedures.
• Partner with cross-functional teams and support documentation process improvements.

Qualifications:

• Associate degree required, or High School Diploma with 3+ years of relevant GMP quality/production experience.
• Minimum 1 year of applicable experience.
• Strong attention to detail and organizational skills.
• Excellent written and verbal English communication skills.
• Proficiency with Microsoft Office and document management systems.
• Ability to manage multiple priorities in a fast-paced, regulated environment.