QC Compliance Specialist

Seqirus•Holly Springs, NC

About The Position

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. 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.

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.

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.
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.
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.