Quality Assurance Specialist - GMP

Job Description

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II. In this role, you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. You will be located at our Oceanside, CA site and report into the Sr. Manager of Quality Assurance Operations.

The standard work week for this position is M–F; however, weekend/night work will be required during manufacturing campaigns to support process operations.

Key Responsibilities (include but are not limited to):

• Perform Quality Assurance related production and production related activities (Batch Record review, Line Clearance, and on the floor support)
• Provide Quality oversight/approval of Quality Control activities (Method transfer, Certificate of Analysis, and Stability)
• Approve shipments and provide oversight during packaging of product
• Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls
• Ensure timely assessment and closure of Laboratory Investigations
• Ensure timely assessment and closure of batch and material hold events
• Communicate lot disposition pending issues to Management
• Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the areas
• Perform walk-throughs and process observations
• Perform Document Control administrative activities including archival and updating of site training records
• Support Regulatory Body Inspections of the facility
• Ensure products are manufactured in compliance with regulatory and GMP guidelines
• Escalate issues that may adversely impact timely release of product
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution
• Generate and update procedures and forms as needed
• Perform additional duties as needed

Basic Qualifications:

• Master’s Degree and
• OR
• Bachelor’s Degree and 2 years’ experience in the biological sciences or related field
• OR
• AA Degree and 4 years’ experience in the biological sciences or related field
• OR
• High School Degree and 5 years’ experience in the biological sciences or related field

Preferred Qualifications:

• Quality Control background in Analytical, Virological, and Microbiological testing
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Proficient in MS Word, Excel, Power Point and other applications. Experience with Veeva, Smartsheet and LIMS is highly desirable
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities