QC Compliance Specialist

CSL Plasma; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

CSL Plasma is seeking a Quality Control Investigator to lead deviation investigations, identify root causes, and implement CAPAs to prevent recurrence. You will use established tools and data systems to manage investigations, coordinate teams, and maintain compliance.

The role supports lean lab operations and continual improvement, providing technical QC guidance and ensuring timely resolution of issues through documented processes and cross-department collaboration.

Qualifications

• Bachelor's degree and 2+ years' experience or equivalent (minimum).
• Basic knowledge of cGMP and FDA requirements preferred
• Knowledge of Laboratory Systems and Investigation/Deviation writing required
• Excellent organizational, planning and time management skills.
• Strong oral, written and interpersonal communication skills.
• Demonstrated technical writing skills.
• The ability to work effectively in both a team environment and an individual contributor role.

Responsibilities

• Leads deviation (DR) investigations to identify root cause and implement CAPAs to prevent reoccurrence.
• Employs standardized root cause analysis, investigation tools and methodologies.
• Own CAPAs and coordinate with investigation teams for resolution.
• Utilizes Investigation and Deviation systems for QC investigations, tracking statuses, and serving as QC liaison.
• Participates in lean lab operations and continuous improvement to maximize efficiency.
• Provides technical support with assigned QC area and with business process systems (SAP, LIMS, Data Historian, Trackwise).
• Responsible for Work Order Tracking system coordination for initiation, execution and completion of work orders.
• Complies with policies to maintain regulatory compliance and safety.
• Reviews trends of QC deviations to identify areas needing action.
• Maintains departmental metrics and KPIs for Senior leadership review.
• Owns, develops and maintains controlled documents.

Skills

Root cause analysis

Investigation writing

Oral & written communication

Technical writing

Team & individual work

Planning & time management

Process improvement

Education

Bachelor's degree

Tools

SAP

LIMS

Data Historian

Trackwise

Work Order Tracking system

Job description

Job Description Summary

Supports the core quality systems including: investigation/deviation management, general CAPA support, incident management, controlled document writing/review, change control support, oversight of vendor work order system

Job Description

Leads deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigation tools and methodologies. Own CAPAs as appropriate.Utilizes Investigation and Deviation systems for owning QC investigations, tracking statuses, leading investigations teams and serve as QC liaison with other department investigation writers to ensure complete and timely resolution.Participates in lean lab operation and continuous improvement programs to eliminate non-value-add activities/maximize efficiency.Provides technical support with assigned area of QC.Provides support with assigned business process systems to support QC. These systems include SAP, LIMS, Data Historian and Trackwise.Responsible for the Work Order Tracking system for tracking and coordinating the initiation, execution and completion of work orders.Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.Responsible for reviewing trends of QC deviations and investigations to identify areas requiring additional action.Maintains departmental metrics and key performance indicators (KPIs) for Senior leadership review.Owns, develops and maintains controlled documents.

Minimum Requirements

Bachelor's degree and 2+ years' experience or equivalent (minimum).Basic knowledge of cGMP and FDA requirements preferredKnowledge of Laboratory Systems and Investigation/Deviation writing requiredExcellent organizational, planning and time management skills.Strong oral, written and interpersonal communication skills. Demonstrated technical writing skills.The ability to work effectively in both a team environment and an individual contributor role.