Quality Assurance Specialist

Duration: 12 Months+

Shifts: Standard

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, nd 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