Quality Assurance Specialist II

Job Title: Quality Assurance Specialist II
Location: Oceanside, CA
Employment Type: Contract
Pay Rate: $34.24 – $44.24/hr

About the Opportunity
ATR International is seeking a highly motivated Quality Assurance Specialist II to support a leading biopharmaceutical manufacturing site in Oceanside, CA. In this role, you will execute a variety of quality activities to ensure compliance with applicable quality objectives and regulatory requirements, reporting into the Sr. Manager of Quality Assurance Operations. The standard work week is Monday–Friday; however, weekend/night work will be required during manufacturing campaigns to support process operations.

Key Responsibilities

• Provide QA oversight and approval of deviation, OOS, and change control records with moderate to significant levels of complexity and/or novelty; ensure records are properly initiated, investigated, and resolved within established timelines
• Provide QA oversight and approval of CAPA and EV records with moderate to significant levels of complexity and/or novelty; ensure CAPAs are initiated and resolved in a timely manner
• Ensure escalation of deviations per procedures
• Identify efficiencies in the execution of the Deviation and CAPA processes in a compliant manner
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility, equipment, and material issues
• Additional duties as assigned; duties may be delegated to designated deputies of a satisfactory qualification level as needed

Basic Qualifications

• Master's Degree, OR
• Bachelor's Degree with 2+ years' experience in biological sciences or related field, OR
• AA Degree with 4+ years' experience in biological sciences or related field, OR
• High School Diploma with 5+ years' experience in 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 with U.S. and EU standards
• Ability to effectively negotiate and build collaboration among individuals
• Proficient in MS Word, Excel, PowerPoint, and other applications
• Excellent interpersonal, verbal, and written communication skills essential in a collaborative work environment
• Comfortable in a fast-paced, small-company environment and able to adjust workload based on changing priorities

ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.