We are seeking a talented Technical Writer to support the Facilities Management Department in maintaining compliance with cGMP standards. This is an onsite role based in Rensselaer, NY.

Responsibilities:

• Act as a liaison between the Facilities Department and quality/regulatory teams to address and resolve compliance issues.
• Manage and participate in investigations related to non-conformities, ensuring timely resolutions in alignment with procedures and regulatory requirements.
• Facilitate reviews and updates of Standard Operating Procedures, Work Instructions, Risk Assessments, and OJT Task Evaluations within the Facilities Department.
• Provide guidance and support for documentation processes, including Change Controls and Corrective and Preventive Action (CAPA) plans.
• Participate in quality and regulatory audits, addressing any findings related to the Facilities Department.

Qualifications:

• Bachelor’s degree is required. Relevant experience can substitute for educational requirements.
• Have strong technical writing skills, preferably within a manufacturing or pharmaceutical environment.
• Can prioritize and manage multiple assignments in a fast-paced setting.
• Understand equipment and terminology used in manufacturing operations.
• Are detail-oriented, organized, and excel in cross-functional collaboration.