RAQA Technical Writer
Location: Kalamazoo, Michigan
About Our Client:
Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction. Working at this company will give you the opportunity to work with some of the top technical professionals in the industry who are bringing cutting-edge products to forefront. Offering results-driven people a place where they can truly make a difference on a daily basis, this is an opportunity you will not want to miss!
Key Responsibilities:
- Implementing quality standards and ensuring compliance at every stage of the process.
- Assessing potential risks, maintaining compliance, and providing recommendations for improvement.
- Taking responsibility for all quality control aspects of the process, including laboratory studies, clinical research, testing, operations, raw materials, production, and finished products or services.
- Facilitating audits and regulatory inspections to ensure readiness and adherence to standards.
- Coordinating quality training sessions to promote adherence to quality practices across teams.
- Developing, standardizing, and maintaining clear, accurate documentation such as operating procedures, work instructions, and forms.
- Ensuring all documentation complies with internal standards, regulatory requirements, and best practices for clarity, consistency, and usability.
- Collaborating closely with subject matter experts (SMEs), process owners, and cross-functional teams to capturing complex processes and translating them into user-friendly documentation.
Qualifications:
- Bachelor’s degree in Engineering, Technical Communication, Life Sciences, or a related field
- 3+ years of experience in technical writing, preferably within regulated industries (e.g., medical devices, pharmaceuticals, manufacturing).
- Familiarity with Quality Management Systems (ISO 9001, ISO 13485).
- Supporting regulatory compliance efforts, including audits and inspections.
- Conducting risk assessments such as CAPAs, NCRs, and Gap Analyses.
- Contributing to M&A integration and process harmonization.
- Using document control and quality management software tools.
- NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company
