M-F Full Time
Scope of Function:
Responsible for performing duties related to the oversight of the Facilities Department and when required, quality assurance activities in accordance with cGMP and standard operating procedures.
1) Oversee and Maintain Amega Monitoring System and Ensure Immediate Notification to the Facilities, Manufacturing and QA Management of Any Excursions.
2) Review & Oversee Equipment Related Qualifications and Validations.
3) Review of Documentation Related to the Cleaning of the cGMP Manufacturing Areas.
4) Review of Preventative and Unscheduled Maintenance.
5) Review of Calibration Records.
6) Initiate and/or Oversee Exception Documents Related to Facilities and Ensure Timely Closure.
7) Oversee and Maintain Documentation Related to Pest Control.
8) Coordinate with QA Documentation Control in relation to proper documentation and document filing/archive.
9) Assist in Internal and External Audits.
10) Assist with other QA related tasks as delegated by QA/QC Director or QA Manager.
Education, Experience and Skills required:
Bachelor’s degree in Life Sciences or a related scientific field. Fully conversant with word processing, spreadsheet and database computer programs. Communicates and Multi-tasks effectively. 3-4 years working experience in QA, preferably in a GMP environment.
Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Project Management, Materials Management, Purchasing, Client, Senior Management, Process Development Scientists.
Goodwin Biotech - 15 months ago
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