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Nesco Resource · 4 hours ago

IT Quality Systems Specialist

Fall River, MA

Full-time

Onsite

Entry Level

$70K/yr - $95K/yr

2+ years exp

Nesco Resource is seeking an IT Quality Systems Specialist to join their Pharmaceuticals Quality Team. This role is responsible for ensuring data integrity and compliance within electronic laboratory and equipment data, supporting quality investigations and continuous improvement initiatives in alignment with regulatory requirements.

ConsultingHuman ResourcesStaffing Agency

No H1B

Responsibilities

Serve as a Subject Matter Expert (SME) for IT-related activities supporting Quality Management System (QMS) platforms and other regulated electronic systems requiring compliance with 21 CFR Part 11

Monitor and review audit trails and electronic records to identify irregularities, unauthorized changes, or trends that could impact data integrity or product quality

Perform routine analysis of electronic data to proactively identify risks, trends, and opportunities for process improvement

Provide training to laboratory and manufacturing personnel on the proper use of digital platforms supporting GMP and GLP activities, with emphasis on audit trail integrity, data integrity, and cGMP compliance

Support investigations related to electronic data issues and participate in the development and implementation of corrective and preventive actions (CAPAs)

Collaborate cross-functionally with Quality, IT, Laboratory, and Manufacturing teams to ensure compliant system use and documentation practices

Qualification

Quality AssuranceCGMP complianceElectronic records reviewData analysisMicrosoft ExcelCommunication skillsAttention to detailOrganizational skillsProblem-solving

Required

Bachelor's degree (B.Sc.) in a scientific discipline related to the pharmaceutical industry (e.g., Biology, Chemistry, Pharmacology, Biochemistry)

Minimum of two (2) years of Quality Assurance experience in a GMP-regulated pharmaceutical manufacturing environment, supporting Quality Control Laboratory and Manufacturing Operations

Working knowledge of quality systems related to electronic data generation, storage, retrieval, archival, and audit is required

Strong understanding of current Good Manufacturing Practices (cGMP)

Experience reviewing electronic records and audit trails in regulated systems

Aptitude for quantitative problem-solving, data analysis, and advanced analytics

Experience writing and executing performance or system-related tests

Strong database, computer, and data visualization skills

Advanced proficiency in Microsoft Excel

Excellent attention to detail with the ability to prioritize and manage multiple tasks under strict deadlines

Self-motivated, proactive, and capable of working independently with minimal supervision

Strong organizational, written, verbal, and presentation communication skills