Position Details
Documentation Specialist Apply
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Job Title: Documentation Specialist / QA Documentation Specialist I
Location: Bend, OR
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift Days: Monday to Friday
Summary
The role involves supporting the implementation and continuous improvement of Quality Systems in compliance with GMP regulations. It includes managing controlled records and documents, maintaining proper documentation processes, and assisting in audit activities to ensure regulatory compliance.
Key Responsibilities
- Continuously develop and maintain knowledge of GMP regulations.
- Support implementation and continuous improvement of Quality Systems.
- Manage record control, including receipt, reconciliation, scanning, verification, check-in/check-out, and maintaining scanned backups.
- Issue and track controlled documents and numbering.
- Support internal and external audit activities.
- Perform additional duties as assigned.
Level of Authority
- Accountable for accuracy of assigned work.
- Provides guidance on GMP practices and procedures.
- High School Diploma or GED required.
- Prior experience working in a GMP-regulated or quality-driven environment.
- Basic understanding of audit processes and regulatory documentation requirements.
- Familiarity with document control systems or electronic quality management systems (eQMS).
- Strong attention to detail.
- Excellent oral and written communication skills.
- Proficiency in Microsoft Word and Excel.
- Self-motivated with a positive attitude.
- Ability to collaborate effectively with cross-functional teams in a fast-paced environment.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
