QA Associate at HAYS in Olympia, Washington

Job Description:

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.


Applicants must be legally authorized to work in the United States. Sponsorship not available.


Our client is seeking a QA Associate in Bothell, WA.



Role Description


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. Requirements:



Skills & Requirements



Documentation Review experience - Scientific Degree - Experience working in a GMP environment
*Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.
* Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews.
• 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



Benefits/Other Compensation


This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).



Why Hays?



You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.


Nervous about an upcoming interview? Unsure how to write a new resume?


Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.


Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.


In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.


Drug testing may be required; please contact a recruiter for more information.


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#1162195 - Laurie McComb