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Quality Systems Specialist II
3 months ago
Working as our Quality Systems Specialist for our Woodinville, WA site, you will represent Quality Assurance during cross functional meetings to ensure the effectiveness of the Seattle Operations site Quality Management Systems. You will directly support and contribute to actions for the Change Management Board, Validation Review Board, Material Review Board, training program, Management Review, product release, FDA surveillance and site quality initiatives. You will also review quality records and initiate and investigate non-conformities when identified.
How You'll Make An Impact:
You will support release of high-quality product by conducting thorough quality review of documentation to ensure compliance.
Maintain the integrity of the QMS and provides confidence to internal and external customers by following through on actions and continually improving quality processes.
Work with operations personnel to continually improve procedures and methods.
Analyze and prepare data for reports and recommendations for management reviews.
Facilitate Quality boards and supports participants by completing associated quality documentation.
What You Bring:
- You have an Associate degree or equivalent in Biology, Chemistry, or related field.
- 2+ years experience in quality, quality systems or regulatory affairs in a regulated manufacturing industry or equivalent combination of education and experience.
- You have an understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
- Technical writing experience and project management experience preferred. You have a etail-orientation and have experience multitasking.
- You have solid decision making, time management, organization, communication, leadership, and computer skills.
Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.
Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more
Compensation: The estimated base salary range for this position is $70,200 to $96,600 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.
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