- 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
- Associate degree from an accredited educational institution.
- Working knowledge of Microsoft Office products, especially Word, Excel, Outlook and PowerPoint.
- 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)
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
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Quality Assurance Associate - Middleton, United States - LGC, Biosearch Technologies
Description
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.
Qualifications:
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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