QA Specialist II

Job Description

Job Summary:

• 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

Duties and Responsibilities:

• 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.

Education and Experience:

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

Knowledge, Skills, and Abilities:

• 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.