Professional Technical Writer

Professional Technical Writer

Requirements

• High School Diploma and 3+ years’ cGMP experience
• Associate’s degree and 2+ years’ cGMP experience
• Bachelor’s degree and 0+ years’ cGMP experience.

Responsibilities

• Authoring document revisions as required per administrative, deviation, CAPA, Change Control and Audit Observations.
• Maintaining their items within a state of control and driving to meet site priorities.
• Maintaining a state of compliance on the manufacturing floor for official documents and logbooks.
• Maintains records requiring retention per site policies.
• Ensure all Quality Systems operations are conducted in compliance with Health, Safety, Environment regulations.
• Responsible for engaging, investigating and correcting departures from expectations to ensure the highest safety standards are maintained.
• Ensures documents are written in a compliant manner and serves as reviewer/approver of those items as required.
• Track logbooks and maintain record retention records, as appropriate.
• Participates in the training process for new team members/processes.
• Completes CAPA / CCR actions as required.
• Responsible for the associated Biologics Quality System function to ensure sufficient bulk product is released at the appropriate time and quality level to meet requirements for domestic, foreign and contracted vaccine sales.
• Participate and support cost reduction initiatives, as assigned.
• Aide in the development of a highly trained organization that is able to respond to a wide variety of demands while respecting the company values and culture.
• Ensure representation at Level 1 and/or Level 2 +QDCI boards and understand their connection to the Biologics Manufacturing Level 3 boards.

Preferred Qualifications

• Strong leadership skills required to lead in a quality focused manufacturing environment.
• Strong cross-functional working skills to cut across boundaries within and outside Biologics Manufacturing.