6 month contract
Location: Saint Louis, MO 63148 (Westport)
DESCRIPTION OF SERVICES:
Technical Writer will prepare new and revised documents such as forms, standard operating procedures, and batch records. Ensure content accuracy and conformance to established standards. She will assist the department Manager in the overall direction, coordination, preparation and approval of controlled documentation, which will result in the affectivity and control of quality manufactured products, in accordance with production operating systems, procedures, compendia and quality control standards.
· Analyze existing procedures for concurrence with correct department methods and production records relative to company policies, governmental regulations and license requirements. Specifically documents related to test methods, batch records, material specifications, standard operating procedures, and manufacturing and laboratory forms.
· Write procedures that reflect the most effective systems within company policies and government regulations to reduce misunderstanding and usability.
· Determine if existing documentation/procedures:
· Current and that there is consistency between similar documents.
· Meets internal control policies and regulations.
· Changes are required to current procedures based on investigation, audit responses, developmental, or compendia revisions.
· Is/are required or redundant.
· Review and approve GMP training guides in accordance with regulatory and company policies.
· Review requested form revision and impact of the change against SOP, batch cards, test method. etc.
Degree Preferred, (Associate or Bachelors)