Manager, Quality

CyVek, Inc.; Wallingford (CT); On-site; USD 92,000 - 151,000; Full time

Benefits offered by this job

Insurance benefits starting day one

401(k) + ESPP

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Tuition reimbursement

Mentorship programs

Job summary

Bio-Techne, based in Wallingford, CT, seeks a Quality Management System lead to manage document control, training, validations, CAPA, NCMRs and deviations. You will oversee qualification of new processes and support software validation. Ideal candidates hold a Bachelor’s degree with 8+ years of experience (or Master’s with 2–5 years), plus proven leadership and strong MS Word/Excel skills.

Onsite work with standard lab environment. Competitive pay range: $91,700–$150,800.

Qualifications

• Bachelor’s degree with 8+ years of relevant experience, or master’s with 2–5 years.
• Demonstrated leadership capacity with 3–5 years of leadership experience.
• Experience leading quality management systems and process improvements.

Responsibilities

• Write, review & approve SOPs, COAs, deviations, and Change Impact Assessments.
• Lead to ensure compliance with Wallingford QMS.
• Resolve non-conformances and optimize processes.
• Identify and implement process improvements and optimization.
• Lead QMS review and improvement processes.

Skills

Leadership

Data analysis

Communication

Organization

Independent work

Project leadership

Training

Education

Bachelor’s degree + 8+ years experience

Master’s degree + 2–5 years experience

Tools

Microsoft Word

Microsoft Excel

Job description

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: $91,700.00 - $150,800.00

Position Summary

Position will manage the Quality Management System activities of Bio-Techne's Wallingford site, including but not limited to document control, training, validations, CAPA, NCMRs and deviations among others. This position will lead the qualification process related to the new processes and process improvements may also assist with the software validation process.

Key Responsibilities

• Write, review & approve the following as appropriate: SOP, COA, Deviation, & Change Impact Assessment
• Lead process to ensure compliance with Wallingford Quality Management System.
• Leads process to solve product and process related issues and non-conformances and optimization
• Lead process to identify and implement process improvement and optimization.
• Lead quality management system review and improvement process.
• Approval of all new and updated process validations.
• Collaborate with development and facilitate new product/process design and validation
• Follow guidelines and comply with all company safety, quality, and training procedures and regulations
• Perform additional duties as assigned.

Education and Experience

• Bachelor’s degree and 8 or more years of relevant experience
• Or, Master’s degree in a related field and 2-5 years of relevant experience
• Demonstrated leadership capacity with 3-5 years of formal or informal leadership experience.

Knowledge, Skills, and Abilities

• Ability to lead a team of various skills levels and background.
• Working knowledge of Microsoft Word and Excel is required
• Must be able to work in a fast-faced environment where you will be required to prioritize your own work and the work of others to meet various project deadlines
• Must be able to analyze data to make effective decisions
• Must have good verbal and written communication skills, especially across different groups
• Must have strong organizational skills and attention to detail
• Must work well independently in an environment that requires strategic decision making
• Proficient in planning, organizational, and multi-tasking skills to complete assignments in an efficient manner in a fast-paced environment.
• Must be able to effectively train new employees
• Must be able to effectively lead new projects, especially across different groups
• Must stay informed of current trends and developments in area of expertise

Working Conditions

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment.
• Standard schedule hours with occasional variation depending on production needs.
• Onsite work required during standard business hours.

Physical Requirements

• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.
• Manual dexterity required for laboratory equipment and fine measurement techniques.
• Ability to work at a computer for extended periods.
• Ability to lift and handle materials weighing 5–20 lbs.

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.

This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status).

If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance.

Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.