Technical Writer

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
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
Job description
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.