Quality Control Analyst I

ABOUT LGC CLINICAL DIAGNOSTICS:

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

The primary focus area and scope of this position is characterization of biological materials and providing support to manufacturing with timely and accurate in-process and final product testing. The business departments (outside the immediate team) that this role will be working closely with on a regular basis are manufacturing, disease state procurement, and materials management.

To perform this job successfully, an individual must be able to capably perform each of the following essential functions: 

Primary duties

• Accurately perform routine testing with ELISA, immunoassays, bioburden, Western Blot, endotoxin and sterility testing, and other test methods on infectious and non-infectious raw material samples and finished biological products.
• Analyze and record testing data with a focus on accuracy with the awareness that timely work impacts other groups to meet critical customer deadlines.  
• Perform routine clean room environmental monitoring and water system sampling.
• Ensure testing equipment is calibrated prior to use.
• Perform weekly and monthly preventative maintenance to ensure equipment is working properly.
• Maintain an accurate electronic database of sample submission, testing, and final disposition.
• Produce and use control charts. Perform tracking and trend analysis on laboratory data. 
• Performs quality control duties including, but not limited to; daily temperature log entries, emptying biohazard trash, etc.
• Document technical problems, report problems to Supervisor.
• Maintain a high quality of work that has the potential to impact valuable product results, which are critical to customers.
• Enter test results into an electronic database, scan and file the paper record.
• Adherence to company Standard Operating Procedures, as well as, regulatory agencies and customer requirements.
• Comply with cGMP and ISO standards at all times to support LGC’s commitment to Quality.
• Assist with the implementation of corrective actions in response to internal and external audits.
• Maintain the appearance of the QC lab on a daily basis for audit readiness.
• Follow Operational Excellence principles, e.g. removal and disposal of expired chemicals and reagents, removal of broken equipment and unused equipment and supplies from the laboratory.
• Perform other duties as required, or assigned by management, to meet business needs.

Minimum Qualifications:

• Bachelor’s degree in science or related field with 1-2 years related experience
• An understanding of immunoassays is required.
• Ability to work on problems of simple scope where analysis of situations or data requires a review of a variety of factors.
• Excellent verbal and written communication skills in English are essential, including the ability to communicate technical problems in a clear, concise manner.
• Action oriented, able to take initiative to perform routine tasks without being asked.
• Experience with Microsoft Software (Word, Excel, Office).
• Basic mathematical skills are required.
• Good organizational skills
• Sharp attention to detail
• Must be a positive team player with excellent interpersonal skills. 

Preferred Qualifications:

• Skilled in performing ELISA’s is desirable.
• Previous experience with automated chemistry analyzers and immunoanalyzers is desirable.
• Previous experience in a regulated laboratory setting is desirable.

Competencies & Behaviours:

• Resonate and operate in line with LGC’s core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect
• Continuous learner, always seeking opportunities to learn how to perform new assays.
• Adaptable, with the capacity/flexibility to respond to the demands of a growing/changing company.
• Complete the existing workload under supervision.
• Communicate & collaborate across teams for day-to-day activities.
• Possess a strong work ethic
• Performance driven

Join LGC and become part of a team that values collaboration, integrity, and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission.

Our values:

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities 

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, parental responsibilities, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership. 

For more information about LGC, please visit our website www.lgcgroup.com

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