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American Cybersystems

QA Associate

American Cybersystems, Bothell, Washington, United States, 98021


Innova Solutions is immediately hiring for a QA Associate Position type: Full-time Contract Duration: 12 Months Location: Bothell, WA 98021 (Onsite) Shift : Sunday-Wednesday, 9PM - 7:30AM PST As a QA Associate, you will: Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits. 1. Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs. 2. Inspects and releases intermediates or packaged drug product per specifications. 3. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications. 4. Drafts and reviews specifications and SOPs. 5. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data. 6. May provide guidance to less experienced staff. 7. Provides sitewide support during daily walkthroughs of GMP areas. Top Skills - - Documentation Review experience - Scientific Degree - Experience working in a GMP environment Requirements: • B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred. • 2+ years of relevant experience in a regulated environment with at least 2 years focused on product quality. • Knowledge of biotech product manufacturing. • Knowledge of US and EU cGMP regulations and guidance. • Knowledge of Oracle, BMRAM, MES, Veeva Infinity are a plus Vinay Bhatiya Associate- Recruitment PAY RANGE AND BENEFITS: Pay Range*: $32.00 - $36.00 per hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: * One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) * ClearlyRated® Client Diamond Award Winner (2020) * One of the Largest Certified MBE Companies in the NMSDC Network (2022) * Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, To view the full job