Quality Control Specialist
About The Position
The Quality Control (QC) Specialist- Incoming supports inspection of inventory reagents, R&D materials, consumables, finished goods, and kits sent to customers to ensure they meet quality standards and regulatory requirements. The role performs detailed inspections and evaluations against established specifications, helps ensure compliance with industry regulations, company policies, and QC protocols, and assists QC leadership with inspection activities in the laboratory and receiving area. The position collaborates with supply chain, quality assurance, laboratory operations, supplier quality teams, and other cross-functional groups. It also supports inspection process documentation, deviation and CAPA activities, vendor performance metrics, process improvement, and training of new QC staff. This position requires periodic travel and some evenings, weekends, and/or holidays.
Requirements
- High school diploma and 1–2 years of experience in material management, quality control, or a related field.
- Hands-on experience performing Incoming Quality Control inspections.
- Working knowledge and understanding of Quality Systems, including document control, audits, and Management Review.
- Ability to perform duties independently with minimal supervision in a regulated environment.
- Strong written and verbal communication skills.
- Attention to detail and ability to identify discrepancies.
- Ability to sit, stand, and/or work at a computer for long periods.
- Visual acuity and analytical skill to distinguish fine detail.
- Ability to pass a visual color discrimination test.
- Ability to lift up to 30 pounds.
- Availability for periodic travel and some evenings, weekends, and/or holidays.
Nice To Haves
- Associate or Bachelor's degree.
- Knowledge of FDA-regulated industry standards and regulations.
- Willingness to learn and adapt to new processes and technologies.
- Proficiency in Microsoft Office Suite, specifically Word, Excel, and Outlook, and general working knowledge of the Internet for business use.
- Proficient verbal and written communication, including willingness to share and receive information and ideas across all organizational levels.
- Commitment to team and organizational goals and willingness to participate with and help other team members.
Responsibilities
- Inspect reagents, consumables, and R&D materials against established production acceptance criteria.
- Inspect manufactured products to verify that components and labeling comply with regulatory and quality requirements.
- Inspect sample- and test-specific collection kits that will be sent to customers.
- Develop and maintain inspection methodologies, SOPs, and job aides.
- Initiate deviations in the eQMS when specifications are not met and participate in material-related CAPA investigations.
- Perform inspections and maintain accurate, timely records and related documentation.
- Assist other QC functions with creating and maintaining documentation needed to comply with regulatory standards.
- Collaborate with supply chain, quality assurance, and laboratory operations to meet business requirements while adhering to regulatory standards.
- Work with cross-functional groups and supplier teams to address major quality issues involving products or manufactured kits.
- Coordinate with supplier quality teams to assist in developing vendor performance metrics aligned with quality standards and internal processes.
- Identify and recommend opportunities to improve QC processes.
- Assist in training new QC staff and support the team as needed.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
