PURPOSE AND SCOPE OF POSITION:
The Facilities Compliance Associate will be responsible for all duties listed below, under the minimal direction of the Facilities Compliance Specialist.
The Associate will support Facilities compliance by overseeing GxP documentation including creation and revision of Standard Operating Practices (SOPs) and associated Work Instructions (WIN). The Associate will be responsible in performing F&E related deviation investigations and CAPA.
DUTIES AND RESPONSIBILITIES:
- Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.
- Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMP’s, and safety.
- Participate in the development and revisions to the Facilities & Engineering training program.
- Write and revise Facilities SOPs as required.
- Execute Deviations, CAPA plans
- Excellent communication skills, both verbal and written.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Requires a Bachelor’s degree or equivalent
- Must have a minimum of 0-2 years’ experience performing deviation investigations and CAPA
- 0 -2 years directly related experience in cGMP manufacturing facility, Biotechnology, Medical Devices or Pharmaceuticals Company.
- Must have 0-2 years of experience with Computerized Maintenance Management System (CMMS) and Building Automation System (BAS).
- Must have demonstrated ability to effectively support operations in a GMP and/or GLP environment, preferably with Aseptic Technique and clean room protocol experience.
Knowledge, Skills, and Abilities
- Must have the ability to work with people at varying levels within the company and varying technical backgrounds.
- Demonstrated ability to follow SOP’s and works within GMP guidelines.
- Must have knowledge of technical writing.
- Proactive, highly organized, detail oriented and self-directed.
- Ability to work independently and manage multiple tasks.
- Proficient in Microsoft Office