Technical Quality Assurance Lead

FCX Performance•Raleigh, NC

5d•Hybrid

About The Position

The Technical QA Lead reports to the Quality Manager or Manager of Training. This position is an exempt position. Fifty percent travel may be required. This is based on a scheduled need and requirement. Expectations: The Technical QA Lead will be actively engaged with PCI Customers and with PCI work product. The Technical QA Lead will be engaged with Field Operations and Metrology Operations. The Technical QA Lead is expected to establish, maintain and drive quality standards in accordance with corporate objectives across all business units. This individual is expected to demonstrate a strong knowledge of quality systems in the Pharmaceutical/Biotechnology industry and have a strong grasp on effectively managing multiple priorities. CCMS/CMMS (RAM), Training Database, and other Microsoft products (Excel, Word, PowerPoint) will be utilized frequently and must be used effectively and efficiently by the Technical QA Lead. The Technical QA Lead will have a strong technical background in calibration and metrology technology and practices in order to evaluate and provide corrective training on calibration execution by other associates.

Requirements

A four-year degree in Life Sciences or Quality Assurance, or other related field and six years of industry experience (or the equivalent combination of education and experience).
Extensive relational database experience is also required.
Self motivated individual who exhibits a professional demeanor, and enthusiasm
Excellent organizational, analytical, problem solving and team player skills
Strong interpersonal skills to interact confidently with clients and employees
Possess excellent oral and written communication skills
High attention to detail
Effective organization and prioritization skills
Ability to multitask
Travel to projects in other geographical locations
Join PCI Business Review Meetings when applicable
Strong computer and database skills
Experienced with Microsoft Office products

Responsibilities

Review and engagement with PCI Customer Compliance Metrics and Scorecards
Engagement with PCI Data Analyst and supporting review and deliverables of PCI work product
Support on PCI Capital Project Revenue Programs in regard to quality representations, audits, and support
Maintain and continuously improve the Quality System including the Quality Manual
Evaluate, document, and report progress in meeting quality objectives
Promptly address any customer complaints and assist in implementing customer solutions
Manage the corporate document control systems
Ensure compliance of internal programs including change and documentation control processes
Identify areas for continuous improvement initiatives
Own the accreditation process by hosting annual audits and coordinating with internal managers accreditation scope changes
Manage the corporate training database including system administration and end-user training
System administration includes uploading policies and other documents, adding/removing courses and users and ensuring company-wide trainings are up-to-date
Where applicable, provide field training to PCI associates in proper execution of technical calibration activities.
Manage the internal audit program of the quality system
Complete internal and external quality assessments. This will also include Field Audits
Audit and Inspection programs within PCI training programs
Handle client audits; both physical and paper audits
Perform field audits of technical staff to assess proper execution of field calibrations and adherence to PCI policies and procedures as well as GxP practices
Serve as PCI’s Safety Officer and main point of contact for all safety related matters
Lead the Safety Committee and present valuable information back to senior leaders
Execute safety initiatives, handle incident reports, and accurate OSHA logs
Provide field evaluation of safety practices at PCI project sites to confirm adherence to PCI and Client safety program requirements.