Quality Control Associate I

Position Summary:

A Quality Control Associate I is responsible for maintaining a high level of quality and customer satisfaction while meeting production schedules in a fast-paced, high throughput industrial setting. The associate will be responsible for quality control of product types including chemical buffers, biological diluents/reagents, coated plates, and assembled kits for customer order fulfillment. Under minimal supervision, the associate will follow established SOPs to support department goals, assist in troubleshooting, and contribute to continuous improvement of processes and documentation. Some degree of professional latitude, creativity, and self-management is expected.

Duties and Responsibilities:

• With supervision, perform quality control functional testing and data evaluation to determine disposition of all product components
• Perform incoming QC on raw materials and assign disposition prior to production use
• Assist Production and R&D with assay validation and stability testing, including control range establishment
• Support CAPA and deviation investigations by collecting data and drafting initial documentation
• Maintain lot traceability records and support lot release documentation including Certificates of Analysis
• Perform daily record-keeping, scheduling, and disposition, including daily updating of quality control summary databases
• Continually evaluate and update SOPs, technical methods, and other controlled documentation
• Effectively communicate issues that impact timelines, accuracy, or reliability of laboratory data
• Participate in internal audits and support audit readiness activities
• Provide contributions and initiatives for continuing improvement of processes and documentation
• Specific duties may vary depending upon departmental and company requirements

Experience and Qualifications:

• Bachelor's degree in Biochemistry, Microbiology, Chemistry, or related field required
• 0-2 years laboratory experience
• Demonstrated consistency in performance and aptitude for managing additional responsibility

Knowledge, Skills and Abilities:

• Demonstrated excellent laboratory technique in areas relevant to microplate assay performance
• Aptitude for understanding principles of assay development and troubleshooting assay performance issues including OOS results, control failures, and lot-to-lot variability
• Strong scientific fundamentals and analytical background
• Proficient with MS Office; experience with Excel automation preferred
• Excellent interpersonal skills and ability to work well with personnel at all levels
• Effective written and verbal communication skills

Physical Demands:

• Up to 70% of the day may be spent at a lab bench
• Some duties require working at heights above four feet
• Ability to lift up to 25 lbs

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person