Job Details

St Joseph, MO

Contract Duration: 12-36 months

Rate: Negotiable

Salary: NA $1.00

Responsibilities:

• Excellent employment opportunity for a Documentation Specialist I in the St Joseph, MO area.
• Initiate and support workflows in Trackwise (or related) upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards, Special Outlines, Batch Records).
• Issuance of revised documents including archival of superseded documents. Initiate Biennial review workflows for controlled document types (SOPs, forms, quality standards).
• Write, review and update SOPs/forms within IDEA for CON as necessary. Schedule and facilitate cross-functional meetings for periodic reviews of OOPs and Special Outlines.
• Maintain component data stores and make appropriate assignments.
• Perform inventory analysis and adjustments within the SAP database.
• Assist as necessary to maintain systems for equipment log books generation, form maintenance, and other production documentation. Assist with archiving.
• Collects and Trends data as necessary
• Customer service functions include assisting with Change Control workflows. Provides expertise with IDEA for CON workflows.
• Perform all Company business in accordance with all regulations (e.g. EU, APHIS, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain company's excellent reputation in the community.

• Minimum of high school degree or GED and two (2) years' experience in biological production environment or similar
• Experience must be inclusive of documentation systems and Quality assurance requirements.
• Strong computer skills to include Microsoft suite, IDEA for CON, Trackwise / GoTrack and organizational skills.
• Proficient in SAP.
• Excellent attention to detail, communication and written skill sets.
• Ability to draft portions of technical documents and strong proofreading skills.
• Must have experience with IDEA for CON, Trackwise/GoTrack, SAP (or similar business programs/software) and knowledge of production workflows.