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Quality Assurance Engineer Biotech

2 months ago

Middleton, United States LGC Biosearch Technologies Full time

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.

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

Qualifications:
Qualifications

Minimum Qualifications:

Bachelor's degree in engineering or the life sciences—or a related discipline
Previous work experience as a QA Engineer role within a biotechnology, medical device, or pharmaceutical company is required.
Prior experience processing CAPAs, from initiation through verification of effectiveness is required.
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

Preferred Qualifications:
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

Additional Information
What we offer (US based-employees):
Competitive compensation with strong bonus program
Comprehensive medical, dental, and vision benefits for employees and dependents
FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
Deductible Buffer Insurance and Critical Illness Insurance
401(k) retirement plan with matching employer contribution
Company-paid short- and long- term disability, life insurance, and employee assistance program
Flexible work options
Pet Insurance for our furry friends
Enhanced Parental leave of 8 additional weeks
PTO that begins immediately
Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more

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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