Quality Validation Specialist

• 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

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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:

• One location

Work Remotely:

• No