Facilities Gmp Documentation Specialist Ii/Iii (Temporary Assignment For 6 Months)

Job Summary

This role focuses on supporting the Facilities Department’s cGMP Quality records and Document Control requirements, and compliance with requirements from FDA 21 CFR, ISO 13485 and ICH Q10 standards. This role contributes to and supports Alexza/Ferrer’s quality systems to ensure compliance for clinical and commercial distributions.

Responsibilities

• Supports the creation, execution and closure of Change Controls for Validated Equipment and Building Utilities, including Classified ISO-8 Cleanrooms.
• Supports the Quality Records creation, tracking and closure in the Facilities Department including but not limited to Out of Tolerance, Corrective Actions, Validation Reassessments, Approved Supplier Evaluation, Deviations, Investigative Reports, Change Controls, etc.
• Supports the Validation of Equipment and Asset Management Software by assisting in the creation of protocols, execution of protocols, authoring final reports.
• Assist in the record keeping for the Asset Management Software
• Assist in the routing of GMP documents in the Document Control platform.
• Assist in editing and routing of revisions for standard operating procedures and other facilities related documentation.
• General document related resource for the Facilities Department.
• Participate in promoting efficiency of systems with new ideas by providing creative solutions to complex tasks in accordance with company policies.
• Coordinate liquid nitrogen deliveries, testing and release as needed.
• The full documentation life cycle support for the calibration and maintenance programs, both paper and electronic based systems.
• Maintain the maintenance and calibration service reports in the Asset Management platform.

Skills required:

• Excellent communication skills when working with internal and external customers.
• Self-motivated and able to work with minimum supervision.
• Able to follow detailed verbal and written work instructions.
• Some experience with invitations, cost analysis, and root cause analysis.
• Ability to communicate complex and detailed information for successful resolution of Facilities document control matters.
• Ability to use and learn a wide variety of computer applications including MS office, Excel, PowerPoint, computerized asset tracking systems, building management systems and familiar with electronic quality systems.
• Excellent interpersonal skills and the ability to work well with internal and external personnel.
• Nice to have the understanding of building systems.
• Nice to have the ability to work from blueprints, drawings or rough sketches.

Education and experience

• an AA degree or higher
• Level II: minimum 2-5 years relevant experience
• Level III: minimum 5+ years relevant experience
• Technical training, understanding, or on the job experience in Electrical, Electronic, HVAC, or Mechanical Engineering is a plus but not required.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing.
• Must be able to lift up to 15 pounds at times.
• Must be willing to travel.

Compensation:

Starts at $45/hour. Individual title and pay may vary based on additional factors, including, but not limited to, job-related skills, experience, and relevant education or training.