Lighthouse Instruments is currently seeking an experienced Quality Manager OR Manager of Quality to join our talented team.
The Quality Manager OR Manager of Quality is primarily responsible for establishing and maintaining quality systems for the analytical services business unit, providing quality oversight to assigned areas, and supporting quality systems for the product manufacturing business unit. Performs all duties associated with compliance-related items for ISO standards" and cGMPs.
Actively drive quality initiatives.
Analyze data, process capabilities, customer concerns and expectations, and any other leading or lagging indicators, which may be used to improve product and process knowledge.
Performs internal audits to ensure compliance with established procedures and identify quality system weaknesses that need improvement.
Manage the CAPA process, including the review and approval to open new CAPAs and approving CAPA plans, timelines, and verification of effectiveness plans to ensure timely completion within the established goal.
Lead investigation and root cause analysis of internal deviations and non-conformance reports.
Provides expertise and guidance to site personnel using root cause analysis tools for investigations and continuous improvements.
Assists with process, documents, procedures, and forms changes as needed.
Oversee equipment validation and calibration activities.
Perform internal quality systems audits in accordance with ISO standards, including recommending ways to resolve any issues identified by the audits.
Participates in all customer audits, on-site and paper audits.
Performs other duties as required or assigned.
Required: Bachelor’s degree in one of the life sciences
5+ years of Quality related experience in a laboratory environment, preferably cGMP
Knowledge of ISO 9001, ISO 17025, and cGMPs
At Lighthouse Instruments (LHI), we consider our talented team to be our greatest asset. Their health and wellness are vital to the success of our organization. That’s why, as part of our Total Rewards strategy, we offer affordable and comprehensive healthcare coverage with ancillary benefit options to eligible employees and their families beginning the first day of the month following the hire date. Additionally, LHI offers a variety of benefits focused on the professional development, financial, and well-being of our employees.
Our benefits package includes several Medical options, Dental and Vision insurance, Life and AD& D, Voluntary Life, and Disability Insurance. Our Wellness benefits include Mental Health, Employee Assistance Programs (EAP), Fitness & Health Programs, Parental Leave, PTO, and Work-Life Balance such as flex-time. LHI offers generous Tuition Assistance, Company Matching Retirement, Discretionary Bonus potential, Travel Insurance, and much more.
If you are an experienced and qualified professional with scientific and personal integrity, dedication to pursuing excellence, a passion for science and innovation, and a commitment to customer and team respect, please email your cover letter and resume to Human Resources at [email protected].
Lighthouse Instruments LLC is an equal-opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the U.S. includes race, color, religion, natural origin, sex, gender identity, sexual orientation, physical and mental disabilities, pregnancy, genetic information, military or veteran status, or any other protected classification. Equal employment opportunity includes but is not limited to hiring, training, promotion, demotion, transfer, leave of absence, and termination.
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LIGHTHOUSE is the leading global provider of laser-based, non-destructive headspace analysis platforms. Our range of benchtop and in-line platforms with patented laser sensor technology is used to analyze pharmaceutical products and packages and monitor sterile product processes across the product life cycle. In addition to supplying headspace platforms, LIGHTHOUSE offers measurement services and lease equipment from laboratory facilities in Charlottesville, VA, and Amsterdam. Our highly-trained team of Application Scientists supports customers with outsourced testing services, scientific studies, and lease equipment projects.