QC Compliance Specialist

About the role

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

Responsibilities

• 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; owns CAPAs as appropriate.
• Utilizes Investigation and Deviation systems for owning QC investigations, tracking statuses, leading investigations teams and serving 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, including 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.

Requirements

• 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.