Quality Assurance Associate - Middleton, United States - LGC Group

LGC Group Middleton, United States

2 weeks ago

Full time

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 Associate is an entry level role that will play a key role on the company's Quality Assurance (QA) team, ensuring the Quality Management System (QMS) conforms to the relevant ISO quality standard and effectively meets applicable regulatory, customer and LGC business requirements. Quality Assurance Associate will have responsibility for supporting the documentation, effective maintenance, and improvement of the site's Quality Management System to maintain regulatory compliance and ISO certifications.

Effectively execute on operational duties specific to quality training, change management and document control, record review and retention, customer feedback and complaint management, and monitoring and measurement of quality and business objectives
Conduct batch history records (BHR) reviews for completeness, accuracy, and use of good documentation practices prior to approval and product release
Administer the document control process and quality records; serve as subject-matter expert in this area
Serve as the coordinator of the company's quality training, site supplier management program
Assist, as directed, in complaint investigations and developing corrective actions to address complaints
Monitor and report on designated quality/business metrics
Assist with reporting to top management on the performance and integrity of the QMS and needs for improvement
Promote awareness of quality and customer requirements throughout the organization
Partner with Operations to ensure effective administration of QA documentation (Batch History Records and related technical SOP's) and adherence to product labelling requirements
Coordinate with QA team members on the maintenance, execution and improvement of related QMS processes: nonconformances, corrective and preventive action, process/product deviations, training management and complaint management
Support development, maintenance, improvement, and implementation of customer facing documentation (Certificates of Analysis, User Manuals, Application Notes, Customer Quality Questionnaires) as necessary.
Participate in internal and external audits as needed
Promote a positive quality culture welcoming open communication and feedback
Understand and comply with ethical, legal, and regulatory requirements applicable to the business

Qualifications

Minimum Qualifications:

Associate degree from an accredited educational institution.
Working knowledge of Microsoft Office products, especially Word, Excel, Outlook and PowerPoint.

Preferred Qualifications:

Bachelor's degree in Science, Technology, Engineering, or Mathematics-or a related field of study
Prior work experience in a quality role, within a manufacturing or biomanufacturing organization, under a certified or regulated environment (e.g. ISO, GMP, FDA)
Experience working within a quality management system
Certificate in or secondary studies in Quality or a related field of study. Familiarity with international Quality System requirements, particularly ISO 13485, FDA, or GMP
Prior experience in a document and records control or technical writing/procedural writing
Working knowledge of Electronic Quality Management Software (eQMS)

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

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, 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

#scienceforasaferworld

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