Job Description

To establish, revise, and deploy Natrol and Jarrow controlled quality documents (SOPs, Work Instructions, Forms, Templates), quality and regulatory guidelines, and other technical publications. Cross reference documents and evaluate the impact of changes on other controlled documents. Identify discrepancies and actions to be taken to prevent deviations and non-conformances due to incorrect documentation. Ensure all procedural documents are initiated, reviewed, approved, trained, and deployed in a timely manner.

• Collaborate with subject matter experts in impacted departments to draft or to revised controlled quality documents, such as SOPs, Work Instructions, Forms, Templates, and other publications.
• Preparing documents for internal and external review, responding to internal and external reviewer comments, and revising accordingly.
• Utilize templates to rapidly draft and format technical documents.
• Support and prioritize multiple projects concurrently while influencing cross-functional teams to ensure documentation is completed within specified timelines.
• Performs other related duties as assigned.

• Hands-on experience with a paper, electronic or hybrid systems preferred. Strong knowledge of cGMPs required. FDA and/ or other regulatory agency experience preferred.
• Experience with writing quality-related documents to meet requirements of 21 CFR parts110, 111, and 117. Experience with authoring legal documents such as Quality Agreements and Supplier Qualification is a plus.
• Strong written and verbal communication skills, specifically technical, scientific, communications and oral presentations
• Must be very meticulous, well-organized and pay attention to detail.
• Excellent communication skills when communicating with managements, colleagues, and peers.
• Communicates changes and progress; Completes projects on time.
• Interact with all team members as needed and capable of working independently with little supervision.
• Reports to the Quality Director
• Associates Degree or 2 years hands on experience in a cGMP environment.