Quality Control Specialist
Caris Life Sciences
**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 by ensuring all the components and the labels are within the finished goods meets regulatory requirements
+ Performs inspection of sample and test specific collection kits that will be sent to the customers
+ Performs inspections and documents them in a timely manner and with minimal supervision.
+ 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.
+ Maintains accurate records of inspection results and related documentation.
+ 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 Qualification**
+ Associate's degree.
+ 2-4 years of professional experience receiving and handling materials in a regulated GMP/FDA regulated or diagnostic testing/pharmaceutical (CAP/CLIA) organization and environment.
+ Must have the ability to manage multiple tasks simultaneously.
+ Demonstrated organizational, interpersonal, oral and written skills.
**Preferred Qualifications**
+ 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.
+ Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
+ Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.
**Physical Demands**
+ Must possess ability to sit, stand, and/or work at a computer for long periods of time.
+ May have exposure to blood-borne pathogens, extreme temperatures, high noise levels, fumes and bio-hazardous material/chemicals including formalin in the lab environment.
+ May be required to handle blood-borne pathogens and general laboratory reagents.
+ May be required to lift and/or move reagents and materials.
**Required Training**
+ All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
**Other**
+ This position may require some evenings, weekends and/or holidays.
**Conditions of Employment:** Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.
Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.
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