What are the responsibilities and job description for the Quality Engineer position at Olympia Pharmaceuticals?
General Purpose
Responsible for ensuring quality oversight throughout the engineer systems and facilities. Involved in day-to-day activities within the facilities and equipment used. Ensuring compliance in all GMP areas including but not limited to commissioning and qualification validation of equipment, process validation, process development of equipment. Also oversee the equipment maintenance and calibration.
Quality Engineering
- Owner of Facility Maintenance
- Owner of Equipment Calibration
- Responsible for Continuous Monitoring program – reports, investigation of OOS
- Oversee Equipment Qualification- coordinating contractors, review reports/ approve work
- Team Member of internal auditing process
- Participate in Process Validation
- Engineering QA Oversight
- Lead Engineer – perform, conduct, outsource all engineering related projects
Job Tasks and Responsibilities
- Manage all facilities maintenance to ensure pharmacy is compliance with all federal and state regulation
- Manage all equipment calibration and ensure scheduled calibration is completed prior to expiration
- Manage continuous monitoring program – ensuring monthly reporting, investigation of deviation or OOS
- Manage all equipment qualifications – coordinating contractors or specialist, review all documents received from contractors and approve work
- Active member of internal auditing committee, ensuring facilities and equipment are within required qualification for audits
- Oversight of Process Validation- conducting perform process validation on all products
- Supervise all engineering operation within the facilities
- Oversee the perform/ conduct/ outsource of all engineering related projects
Education and Experience
- Bachelor’s Degree in a engineering
- Experience with implementation of corrective action programs
- Product or industry-specific experience
- Strong computer skills including Microsoft Office and databases
- Knowledge of tools, concepts and methodologies of QA
- Knowledge of relevant regulatory requirements
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Salary : $75,000 - $85,000