- In partnership with process owners and stakeholders, implement, maintain, and improve procedures for the quality management processes under designated area of responsibility.
- Work and communicate effectively across departments to implement QMS improvements and to maintain its effectiveness
- Serve as the process owner for one or more of the following QMS processes or programs: corrective action and preventive action (CAPA); internal QMS audit; support of supplier qualification/monitoring with Group Procurement; nonconforming material; equipment calibration
- Participate in the following QMS activities as assigned: review and release of manufacturing and QC testing batch records; investigate and document root causes of nonconformances
- In conjunction with CAPA owners, facilitate CAPA's through verification of effectiveness
- Assist in the determination and delivery of quality system training requirements
- Generate, review, and approve production deviations, complaint investigations, and nonconformance reports for non-conforming materials
- Review and approve material and product specifications and the acceptance criteria for equipment qualifications and process validations
- Lead by example through continuous learning and diligently following the requirements of the site's QMS
- Bachelor's degree in engineering or the life sciences—or a related discipline
- Previous work experience in a quality role within a biotechnology, medical device, or pharmaceutical company
- Prior experience processing CAPAs, from initiation through verification of effectiveness
- Prior experience internal auditing, document change control, and change management
- Knowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485)
- Basic knowledge of descriptive statistics and its application to sampling plans, specification setting, and process control
- Strong computer skills required, including working knowledge of Microsoft Office suite of products, particularly Word, Excel, PowerPoint, and Visio
- Certified Quality Auditor (CQA), or similar professional certifications in quality management
- Working experience with 21 CFR Part 820 or ISO 13485
- Understanding of genomics and molecular biology products
- Experience in facilitating both Process Failure Mode and Effect Analysis (P-FMEA) and Process Validation (IQ/OQ/PQ)
- Experience in supporting new product development through a product realization and design control process
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
Quality Assurance Engineer - Middleton, United States - LGC Group
Description
Company Description
With manufacturing sites across the US, UK, Germany and Denmark, LGC Biosearch Technologies has plans to continue growing. We deliver mission critical genomics to our diverse customer base in molecular diagnostics, pharma/biotech and agrigenomics. Our integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization.
Job Description
The Quality Assurance Engineer, in conjunction with the Quality Assurance (QA) team, will ensure that the quality management system (QMS) of LGC's Middleton site conforms to the ISO 13485 standard. This role will ensure that all processes, procedures, and practices remain current and compliant with the expected standard. As a business partner to other critical functions, such as Manufacturing, this individual is expected to effectively build and maintain cross-functional working relationships, analyze data to develop appropriate actions, and support a culture of collaboration and accountability.
Qualifications
Minimum Qualifications:
Preferred Qualifications:
Additional Information
ABOUT LGC:
LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for 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
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, pregnancy or maternity, religion, or belief. Short listing, 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
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