Professional Technical Writer

About the position

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Responsible for the safety, quality, and delivery of their performance within the Biologics Quality Systems Group. The Technical Writer/Document Coordinator is responsible for authoring document revisions as required per administrative, deviation, CAPA, Change Control and Audit Observations. The role is responsible to ensure these revisions are completed on time to meet site objectives and maintaining a compliant state on the manufacturing floors. Accountable for the performance of their assignments with respect to all site metrics. They participate in programs to improve employee safety, reduce costs, improve quality, and increase production efficiencies as per established goals. Responsibilities include remaining compliant with cGMP, CBER, and FDA regulations.

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.
• 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.

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.

Benefits

• High-quality healthcare.
• Prevention and wellness programs.
• At least 14 weeks' gender-neutral parental leave.