What are the responsibilities and job description for the Quality Assurance Analyst position at CyVek, Inc.?
By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$52,000.00 - $85,600.00Position Summary:
Reporting to the Quality Supervisor, this position is responsible for planning, executing, and managing activities in the Simple Plex cartridges QC process to ensure that all applicable objectives are met, and the product functions as expected. To be successful in this role candidate needs to be skilled in analytical techniques for analysis of biological assays. This position interfaces with Manufacturing, Process Engineering, Product Support, Assay Development and Quality Assurance.
Key Responsibilities:
- Compile, document, interpret and manage biological data to evaluate the quality of in-process materials and finished goods to either confirm compliance with established quality standards or identify deviations. This includes functional, assay performance, precision, and accuracy testing. Data management comprises analysis and disposition of data produced and curation of that data into a LIMS database.
- Ensure that the final product satisfies the product requirements and meet end-user expectations
- Support deviation and out-of-specification investigations
- Provide recommendations for corrective actions
- Spot areas for improvement to enhance the product's efficiency
- Maintain clear and accurate records
- Attend cross-functional team meeting and present data summaries
- Perform lab work when needed, including preparation of controls and reagents, and performing instrument runs
- Support new product launch activities
- May be responsible for establishing specifications and writing standard operating procedures
- Support other QC operations, like Simple Plex consumables, as needed
Education and Experience:
- Bachelor’s degree in biology, Chemistry or Engineering with 2 years’ experience.
- Non- scientific bachelor’s degree with 4 years’ experience working in a quality position for a GMP or life science related industry.
Knowledge, Skills and Abilities:
- Outstanding analytical skills. R Analysis experience a plus.
- Super user level in Excel and proficient in all Microsoft Windows functions
- Ability to evaluate large volumes of data in a short timeframe
- Strong understanding of quality system regulations and standards
- Experience working within an ISO compliant, or other regulated environment.
- Experience developing, reviewing, deploying Standard Work (WI’s, MI’s, SOPs)
- Strong presentation skills
- Experience with immunoassay methodology a plus
- Demonstrated ability to deliver quality work, with high work accuracy.
- Demonstrated ability to meet project timelines and collaborate with internal team
- Organized with exquisite attention to detail
Why Join Bio-Techne:
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
Salary : $52,000 - $85,600