Quality Control Specialist - Remote

1w1 week ago

LabConnect

Johnson City, US · Full-time · $65,000 – $90,000

About this role

LabConnect partners with pharmaceutical and biotech companies, and CROs to accelerate new medicines development worldwide. As a QC Specialist, review low complexity study setup and amendment documents for accuracy and completeness. This remote role ensures studies are set up correctly via Operational Specification Documents (OSD) and ancillary documents.

Perform QC on laboratory specification documents including Testing Schedules, Blood Volume Charts, Exclusion/Alerts/Blinding programming, Kit components, requisitions, labels, and Laboratory Manuals. Verify document completeness, consistency across related documents like study protocols and budgets, and use of most recent templates. Liaise with departments to resolve issues identified during reviews.

Collaborate closely with Project Initiation, LIS, DM, BDD, Contracts, Project Amendment, and PRM teams. Oversee QC timelines to meet milestones and capture detailed documentation of findings. Work in accordance with ICH Guidelines for Good Clinical Practice, sharing deviations timely with study managers.

Maintain and analyze QC findings for trend analysis, metrics, and process improvements. Support the electronic Quality Management System (eQMS) for quality documents, events, complaints, audits, and CAPAs. Organize and archive quality records ensuring compliance with document control requirements.

Act as liaison between support groups, interfacing with laboratories, BD, Operations, and Data Management for study needs and problem-solving. Facilitate continuous improvement through quality logs, metrics, and dashboards for management review and audits.

Requirements

Familiarity with reviewing low complexity study setup and amendment documents
Knowledge of Operational Specification Documents (OSD) and ancillary study documents
Understanding of ICH Guidelines for Good Clinical Practice
Experience verifying consistency across clinical trial documents like protocols and lab manuals
Proficiency in cross-departmental collaboration for quality resolution
Ability to perform trend analysis on QC findings and metrics
Skill in utilizing electronic Quality Management Systems (eQMS)
Competence in organizing and archiving quality records per document control standards

Responsibilities

QC laboratory specification documents for accuracy including OSD, Testing Schedules, Blood Volume Charts, Exclusion/Alerts/Blinding programming, Kit components, requisitions, labels, and Laboratory Manuals
Verify documents completeness and consistency within and between related documents such as study protocols, budgets, kit components, requisitions, labels, and internal scope of work
Verify documents are completed on most recent template versions
Collaborate cross-departmentally with Project Initiation, LIS, DM, BDD, Contracts, Project Amendment, and PRM teams to resolve QC findings
Oversee and facilitate QC timelines with PRI, Project Amendment, and PRM to meet milestones
Capture detailed documentation of QC findings and analyze for trends, metrics, and process improvements
Support eQMS by assisting with creation, review, issuance, revision, and change control of quality documents
Maintain quality logs, metrics, and dashboards to support audits and continuous improvement