- Support qualification and validation activities, which includes the performance of the following duties:
- Quality review and approval of equipment/instrumentation installation, operation and performance qualification protocols and summary reports.
- Quality review and approval of equipment/instrumentation/process validation protocols and summary reports.
- Quality review and approval of cleaning validation protocols and summary reports.
- Quality review of non-conformances and ability to and assess impact to qualified/validated equipment/instrumentation/processes.
- Review executed documentation to ensure it meets cGMP standards.
- Consult with SMEs and/or Functional Area Managers for technical supervision and complex issue resolution.
- Communicate qualification/validation statuses with area management.
Requirements:
- Bachelor’s Degree, in a scientific field preferred, with a minimum of two – three years working experience in a relevant field required.
- Previous experience with IQ, OQ and PQ validation protocols and summary reports within the pharmaceutical industry preferred.
- Experience with both process validation and equipment validation mandatory
- Detail-oriented with exceptional planning and organizational skills.
- Ability to meet varying deadlines.
- Ability to coordinate projects involving input from multiple participants.
- Ability to establish a good rapport with both technical and non-technical personnel.
- Ability to work independently, when necessary.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction
Job Types: Full-time, Contract
Pay: $30.00 - $35.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- High school or equivalent (Preferred)
Experience:
- Manufacturing: 1 year (Preferred)
- Process and Equipment Validation: 2 years (Required)
- Pharmaceutical: 2 years (Required)
Work Location:
Work Remotely: