Technical Writer – Quality Remediation
Location: Rochester, MI (Onsite)
Pay Rate: $40–$55/hr, depending on experience
Schedule: Full-time, Monday–Friday (anticipated)
Employment Type: Contract
Position Overview: We are seeking an experienced Technical Writer with pharmaceutical, biotechnology, or medical device quality experience to support quality remediation and documentation improvement initiatives in a regulated manufacturing environment.
This opportunity is ideal for a detail-oriented professional with experience developing, revising, and remediating controlled documentation while partnering with Quality, Manufacturing, and cross-functional subject matter experts.
Responsibilities
- Develop, revise, and remediate SOPs, work instructions, and controlled quality documentation.
- Partner with Quality, Manufacturing, and subject matter experts to ensure documentation accuracy, consistency, and compliance.
- Support quality system remediation and documentation improvement initiatives.
- Ensure documentation aligns with applicable GMP, FDA, and quality system requirements.
- Assist with document reviews, gap assessments, and remediation activities.
- Maintain document control standards and ensure appropriate documentation practices.
- Support cross-functional teams in resolving documentation gaps and improving processes.
Qualifications
- Previous Technical Writing experience within pharmaceutical, biotechnology, or medical device environments.
- Experience with GMP documentation, SOPs, and quality systems.
- Familiarity with FDA regulations, document control, and quality remediation activities.
- Strong written communication, editing, and organizational skills.
- Excellent attention to detail and ability to collaborate cross-functionally.
- Ability to work onsite in Rochester, Michigan.
Additional Information
- Contract opportunity supporting quality remediation initiatives.
- Project duration and travel requirements to be confirmed.
- Hourly compensation based on experience and qualifications.
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