Insight Global · 4 days ago
Quality System Specialist
Spring House, PA
Full-time
Onsite
Mid Level
$41.75/hr - $51.65/hr
3+ years expInsight Global is seeking a Quality Compliance Specialist for Bioanalytical Data and Lab Systems. This role is critical in ensuring compliance with policies, quality standards, and regulatory requirements through conducting quality compliance audits and maintaining auditing records.
EmploymentHuman ResourcesRecruitingSales
Hiring Manager
Trevor Clare
Responsibilities
Conduct audits of scientist/engineer records to ensure completeness, accuracy, and appropriateness, including comparing source data to the records for accuracy and analyzing select data in detail
Audit department records and processes related to the bioanalytical data and lab systems, such as feedback surveys, after action reviews, and lab documentation
Prepare records for audits performed by other staff, such as supervisor reviews, project reviews, and internal audits
Identify opportunities for improving the quality and efficiency of records and processes
Participate in the preparation, facilitation, and follow-up activities for regulatory and accreditation surveys
Audit department records and processes related to general department functions, including training records, timekeeping, policy management, lab development plans/assessments/activities, and regulatory records
Complete audits according to an established schedule and procedures
Maintain detailed auditing data, including workload details and documented findings, recommendations, and corrections, for analytics
Inform and educate staff about audit findings, recommendations, and corrections
Report audit findings, recommendations, and corrections to internal leadership and complete follow-up activities as directed
Monitor and follow up on requested audit corrections to ensure completion
Develop audit and documentation/recordkeeping policies, procedures, and workflows
Utilize tools, systems, and methods to organize and catalog various auditing data
Perform data and statistical analysis on auditing data to generate metrics and other tracking and trending analytics
Participate in performance improvement projects
Collaborate with other quality assurance positions within the organization
Participate in department committees, teams, and workgroups
Serve as a backup for quality and regulatory staff duties
Complete ongoing training and professional development
Qualification
Required
Bachelor's Degree or higher in a science-based, quality, or engineering discipline
A minimum of three years of professional experience in industry
Strong knowledge and hands-on experience working with quality management systems, standards, and regulations relevant to the industry, such as Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP)
Proficiency in performing laboratory inspections, audits, investigations, root cause analyses, and corrective actions
Experience working with testing procedures, quality metrics, and statistical analysis
Familiarity with document control, change control, and risk management processes
Experience collaborating with cross-functional teams to ensure compliance and continuous improvement
Preferred
Formal Quality Training including statistical process control or quality related qualification a plus
Benefits
Medical, dental, and vision insurance
HSA
FSA
DCFSA account options
401k retirement account access with employer matching
Paid sick leave
Paid time off
Company
Insight Global
Insight Global provides top talent and staffing solutions that help job seekers find careers in healthcare, finance, IT, and government.
1001-5000 employees
H1B Sponsorship
Insight Global has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (281)
2024 (164)
2023 (75)
2022 (17)
2021 (3)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2010-07-01Acquired
Leadership Team
Jared Streppa
President Of Company’s Technology Division
Recent News
Maryland Daily Record
2025-09-26
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