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. Associate will be responsible for the quality control of many product types including chemical buffers, biological diluents/reagents, coated plates, and/or assembled kits, for customer order fulfillment. The associate will be responsible, under minimal supervision, to follow established SOPs to support the goals of the department. They will be expected to assist in troubleshooting problems and keeping SOPs up to date. Some degree of professional latitude, creativity and self-management is expected. This position may manage very specific aspects of the QC process within the department. 

Duties and Responsibilities:

• With supervision, be able to perform quality control functional testing and data evaluation to determine disposition of all product 
components, including doing kit retesting for expiration date extensions and stability testing functions
• Assist Production and R&D with assay validation and stability testing 
• Provide contributions and initiatives for continuing improvement of processes and documentation efforts
• Be able to make basic laboratory calculations to determine pass/fail criteria of quality testing 
• Perform daily record-keeping and/or scheduling and disposition, including daily updating of quality control summary databases
• Continually evaluate and update SOPs, TMs and other documentation forms
• Independently develop and maintain logical automated data analysis templates and scripts using Microsoft Excel
• Write and verify Certificates of Analysis as needed
• Specific duties may vary depending upon departmental and company requirements
Experience and Qualifications:
• Bachelor’s degree in Biochemistry, Microbiology, or Chemistry or related field is required
• 0-2 years laboratory experience 
• Possess and be able to demonstrate a thorough understanding of quality testing process
• A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration

Knowledge, Skills and Abilities:

• Demonstration of excellent laboratory technique in all areas relevant to performing microplate assays
• Aptitude for understanding of principles of assay development
• Strong scientific fundamentals and analytical background
• Excellent interpersonal skills and ability to work well with personnel at all levels
• Proficient with MS Office
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
 

Physical Demands:

• Up to 70 % of the day may be spent at a lab bench
• There are aspects of the positions duties that require a person in this role to work at heights above four (4) feet 
• Ability to lift up to 25 lbs