Quality Documentation Specialist

Job Description

Job Description

Job Title: Quality Documentation Specialist

Location: 100% Onsite – Chaska, MN 55318

Pay: $30.58/HR W2
Duration: 1 Year
Shift: Monday to Friday, 8:00 AM – 4:30 PM

Overview:

We are seeking a highly detail-oriented and organized Quality Documentation Specialist to support document control processes within a regulated, fast-paced manufacturing environment. This role requires a strong understanding of documentation standards, quality systems, and the ability to manage multiple priorities with a high degree of accuracy.

Top 3 Must-Haves:

• Meticulous attention to detail and strong organizational skills.

• Ability to prioritize and multitask effectively in a fast-paced environment.

• Proactive problem-solving skills with the ability to troubleshoot and address issues independently.

Key Responsibilities:

• Implement redline changes and format engineering documents according to documentation standards.

• Ensure templates and documents maintain consistent guidelines, formatting, and definitions.

• Review documents for accuracy, completeness, and consistency in content, layout, and authorizations.

• Handle filing, scanning, copying, and distributing released documents electronically.

• Manage archived documentation for accessibility and compliance.

Critical Success Factors:

• High attention to detail and organizational abilities.

• Capable of producing accurate, error-free work under tight deadlines.

• Strong multitasking capabilities; adept at resolving issues as they arise.

• Comfortable working independently and collaborating within a team.

• Thorough knowledge of Good Documentation Practices (GDP).

• Team player committed to shared goals and continuous improvement.

Required Qualifications:

• 2+ years of relevant experience in documentation or quality support.

• Prior experience in Quality Assurance (QA) and Quality Management Systems (QMS).

• Experience with Electronic Document Management Systems (EDMS).

• Familiarity with GMP manufacturing environments (preferred).

• Working knowledge of ISO 9001; ISO 13485 is an asset.

• Prior experience supporting Life Science or Medical Device documentation.

• Strong proficiency in Microsoft Office, especially Word (advanced formatting, track changes, headers/footers, tables, etc.).

• Experience with engineering change orders and design documentation.

• Excellent verbal and written communication skills.

Education:

• Degree or diploma in a relevant discipline; QA certification/program completion preferred.