Quality Control Specialist

Position Summary

The Quality Control (QC) Specialist- Incoming is responsible for supporting the inspection of all inventory reagents, R&D materials, consumables, finished goods and kits that are sent to customers meet the required quality standards in compliance with regulatory guidelines. This role involves performing detailed inspections and evaluations to confirm their conformity to established specifications. The QC Specialist ensures that all processes and products adhere to industry regulations, company policies and quality control protocols. Additionally, assists QC leadership in planning and conducting inspection activities in both the lab and receiving area.

Job Responsibilities

• Performs QC inspection of reagents, consumables and R&D materials by evaluating whether associated specifications/requirements meet the established acceptance criteria for production process
• Performs inspection of manufactured products to verify that all components and labeling comply with applicable regulatory and quality requirements
• Performs inspection of sample and test specific collection kits that will be sent to the customers
• Responsible for the development and maintenance of inspection methodologies, along with creating SOP's and job aides for these processes.
• Responsible for initiating deviations in the eQMS when specifications are not met. Along with participating in CAPA investigations related to material to ensure compliance with quality standards.
• Performs inspections and maintains accurate records of inspection results and related documentation in a timely manner
• Assists other QC functions in the organization in creating, maintaining documentation needed to comply with regulatory standards.
• Collaborates closely with supply chain, quality assurance and laboratory operations to facilitate seamless execution of business requirements while adhering to regulatory standards.
• Collaborates with cross-functional groups and supplier teams to address top quality issues for products or manufactured kits
• Collaborates and coordinates with supplier quality teams to assist in developing performance metrics for vendors, ensuring alignment with quality standards and internal processes
• Attention to detail and ability to catch discrepancies.
• Self-motivated with excellent communication and interpersonal skills.
• Identify and recommend opportunities for improving QC processes.
• Assist in training new QC staff and offering support to the team as needed
• Other duties as assigned.

Required Qualifications

• High school diploma with 1-2 years of experience in material management, quality control, or related field
• Hands-on experience performing Incoming Quality Control inspections.
• Working knowledge and understanding of Quality Systems (Document control, audits, Management Review).
• Ability to perform duties independently with minimal supervision in a regulated environment
• Strong written and verbal communication skills.

Preferred Qualifications

• Associate or Bachelor's degree.
• Knowledge of FDA regulated industry standards and regulations
• Willingness to learn and adapt to new processes and technologies
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook and general working knowledge of Internet for business use.
• Communication - Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization to achieve the desired results.
• Teamwork - Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.

Physical Demands

• Must possess ability to sit, stand, and/or work at a computer for long periods of time.
• Visual acuity and analytic skill to distinguish fine detail.
• Ability to pass a visual color discrimination test.
• Ability to lift up to 30 pounds.

Other

• This position requires periodic travel and some evenings, weekends and/or holidays.