Quality Assurance Specialist I

Company Description

LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f/k/a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics, and the Native Antigen Company. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK. LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.

Job Description

The QA Specialist I position will advance LGC Clinical Diagnostics’ purpose of understanding disease to enable precision diagnostics by supporting and giving to LGC Clinical Diagnostics’ product quality and Quality Management System processes. LGC Clinical Diagnostics’ Gaithersburg location is seeking a candidate who is experienced with a working knowledge of quality system requirements, including FDA QSR/cGMP, ISO 13485, and ISO 14971. The successful candidate will have a strong orientation toward root cause analysis, and continuous improvement based on predictive and preventive metrics. The ideal candidate will be able to support and collaborate with commercial and manufacturing teams to ensure customer requirements are translated into internal specifications with continuous feedback loops for evaluating product and process performance.

Key Responsibilities

• Ensure accurate QMS records related to non-conformances, deviations, OOSs, and reworks; work with functional groups to resolve root causes for process issues related to products and services.
• Perform product release activities such as review of labels, batch records, QC results, and environmental monitoring records.
• Review and approve Document Change Requests (DCRs) related to materials, production processes, and test methods.
• Accurate review and approval of records comparing results to internal and customer specifications, SOPs, and established standards for product release.
• Perform internal audits, issue audit reports, and follow up to close out actions that address the findings.

Qualifications

Qualifications

• Strong interpersonal, organizational, verbal, and written communication skills.
• Demonstrates curiosity, adaptability, and dedication; works best in a team environment and actively seeks to further relationships.
• Ability to ask probing questions to understand unstated expectations and underlying issues, understand going for priorities, and facilitate discussions to gain consensus through the problem-solving process.
• Oriented to continuous improvement with a desire to balance the level of control and flexibility in systems based on risk.

Education and/or Experience

• Bachelor’s Degree or Associate’s Degree with at least 2 years experience in a regulated environment.
• Instead of a degree, a proven ability in an environment governed by 21 CFR 210/211, 21 CFR 820, ISO 13485, or related regulations.

Additional Information

LGC is a leading, global life science tools company, providing critical components and solutions for high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of critical tools for genomic analysis and quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range!

Our values

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities

LGC strongly believes that every job applicant and employee should be valued for their talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or parental, 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 (http://www.lgcgroup.com/)

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