Job Title:

CAPA Supervisor

Reports To:

Associate Director, Compliance

Direct Reports:

N/a

Emergency / Absentee Backup:

Associate Director, Compliance

Job Summary:

The CAPA Supervisor is directly responsible for coordinating and ensuring the completion of corrective and preventative actions issued for BioSpectra’s non-conformance programs.  This position is responsible for the review and approval, tracking, trending, reducing occurrences, and reporting of metrics associated with applicable BioSpectra CAPAs.

Essential Duties and Responsibilities:

• Coordinates the investigation, root cause reporting, and CAPA commitment program for non-conformances documented from internal audits, customer audits, discrepancies and facility bi-weekly Quality Inspections.
• Supports the Regulatory Department as needed.
• Recommends modification of existing quality or regulatory standards to achieve performance expectations and compliance within established standards, management expectations and business objectives.
• Performs Quality Inspections and follows up with all observations from previous inspections, as well as tracks the completion of repeat findings by coordinating with appropriate departments.
• Authors and/or revises systems and procedures as necessary based on the commitments approved from a CAPA plan.
• Performs and documents audits and/or gap analysis on quality, regulatory and manufacturing systems and programs.
• Performs or coordinates the corrective actions and preventative actions in response to investigations, gap analysis or area of deficiencies including but not limited to Discrepancy Investigation, Internal Audits, Customer Audits, Health Authority Audits, Cleaning Validation/Verification, and Environmental Monitoring.
• Builds and implements improvement plans with key personnel based on documented findings.
• Performs internal audits as necessary and completes internal audit finding investigations, establishes necessary CAPA plan and ensures completion all necessary portions of the investigation in a timely manner and/or in accordance with approved procedures.
• Performs CAPA follow up plan and ensures commitments are completed and documented.
• Communicates CAPA plan to departments responsible for CAPA completion and tracks and reports CAPA activities as required.  
• Performs CAPA efficiency assessment and reports results to key management personnel.
• Responsible for establishing the necessary plans for the reduction of non-conformance programs including but not limited to Discrepancy Investigations, Internal Audits, and Customer Audits.
• Drives updates and improvements through staff interviews, assessments, document review, meetings, site visits, and business process mapping.
• Completes internal audit efficiency checks, follow up, and reports to management.
• Provides KPI reporting necessary for Regulatory updates and Senior Management Review.
• Performs monthly environmental monitoring as requested by management.
• Compiles cleaning validation/verification and environmental monitoring CAPAs and metrics for continuous improvement and reporting in annual product reviews. 
• Supports and enables environment for best practices.
• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• 4-year Bachelor’s Degree in Science or Engineering.
• Understanding of cGMP & ICH-Q7
• Knowledge of relevant software applications including MS Office and Minitab
• Knowledge of office systems and procedures
• Organized, Thorough, Neat
• Must be able to read, write, speak, and understand English
• Confidentiality

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Repeating motion that may include wrists, hands, and fingers

Work Hours:

• Non-Exempt Position
• Minimum of 8 Hour Shift from, 5 Days a Week, or other agreed upon documented schedule
• Ability and willingness to work from all BioSpectra facilities