Validation Compliance Coordinator

BioPharma Consulting JAD Group is looking for a dedicated Validation Compliance Coordinator to join our team. The Validation Compliance Coordinator assists with the tracking, coordination, and closure of Validation deviations, CAPAs, and change controls / action items, and assists in supporting other validation activities.
Responsibilities:

Functions:

• Responsible for participating in the following activities within the Validation department:
• Support the Validation organization during internal and external audits.
• Support the external and internal Audit Programs to be in an acceptable state of compliance.
• Work with Quality and Validation management to implement changes to validation program improvements.
• Responsible for Validation audit preparations, assisting internal audits and client audits with site documentation collation.
• Coordinates the initiation of new deviations.
• Leads deviation, CAPA, and change control closure for Validation.
• Assists with leading Root Cause Analysis Investigations
• Schedules and facilitates post Validation lessons learned.
• Supports leading the completion of periodic reviews for quality documents.
• Provides and maintains metrics around requalification and periodic reviews, including deviation, CAPA and change control status.

Deviation Investigation:

• Lead investigations for deviations and events.   
• Generate impact assessments for deviations and events.
• Lead investigations including identification of root and/or contributing causes.     
• Ensures required Management and Quality approvals on final investigations while satisfying established due dates.  Facilitates corrective and preventive action agreement with stakeholders. 
• Support client due diligence and Quality audits as well as regulatory inspections. 
• Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

Equipment Compliance Coordination

• Support the routine maintenance and calibration of Validation equipment by the monitoring and scheduling of any preventative or corrective work required.
• Ensure all equipment utilized on the floor for Validation execution is entered correctly into the Building Management System.
• Is the point of contact for client and regulatory inspection support with trends and metrics.
• All other duties as assigned. 

Required Skills & Abilities:

• Excellent oral and written communication skills, interpersonal and organizational skills.
• Excellent organizational, analytical, data review and report writing skills.
• Practical understanding of equipment used in bioprocessing (downstream and/or upstream).
• Proficient with Microsoft Office applications.
• Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
• Ability to multitask and easily prioritize work.
• Experience working in pharmaceutical industry.

Qualifications:

• Bachelor’s Degree in an Engineering discipline or Life Science and four (4) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
• Associate degree and six (6) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.; OR
• High School Diploma or GED and eight (8) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.

Preferred Qualifications:

• Experience authoring CAPAs, change controls, and deviations
• Experience with validation of automated systems and manufacturing processes is a plus.
• Knowledge of FDA regulations and compliance guidelines related to validation.