Technical Quality Assurance Lead

The Technical QA Lead reports to the Quality Manager or Manager of Training. This is an exempt position and may require up to fifty percent travel based on scheduled needs.

Responsibilities

• Technical Quality Deliverables for Customers: Review and engage with PCI Customer Compliance Metrics and Scorecards; collaborate with PCI Data Analyst on PCI work product; support PCI Capital Project Revenue Programs with quality representations, audits, and support.
• Quality Systems: Maintain and continuously improve the Quality System, including the Quality Manual; evaluate, document, and report progress toward quality objectives; promptly address customer complaints and implement solutions; manage corporate document control systems; ensure compliance of internal programs (change and documentation control); identify continuous‑improvement initiatives; own ISO 17025 accreditation process by hosting annual audits and coordinating scope changes.
• Training Systems: Administer the corporate training database (system administration, uploading policies, adding/removing courses and users, keeping trainings up‑to‑date); provide field training to PCI associates on proper execution of technical calibration activities.
• Audits and Investigations: Manage the internal audit program of the quality system; complete internal and external quality assessments, including field audits; handle client audits (physical and paper); perform field audits of technical staff to assess calibration execution and adherence to PCI policies, procedures, and GxP practices.
• Safety: Serve as PCI’s Safety Officer and primary contact for safety matters; lead the Safety Committee and report to senior leaders; execute safety initiatives, handle incident reports, and maintain accurate OSHA logs; evaluate safety practices at PCI project sites to ensure compliance with PCI and client safety program requirements.

Requirements

• A four‑year degree in Life Sciences, Quality Assurance, or a related field, or an equivalent combination of education and experience.
• Six years of industry experience in the pharmaceutical/biotechnology sector (or equivalent).
• Extensive relational database experience.

Skills

• Self‑motivated with a professional demeanor and enthusiasm.
• Excellent organizational, analytical, problem‑solving, and team‑player abilities.
• Strong interpersonal skills for confident interaction with clients and employees.
• Outstanding oral and written communication skills.
• High attention to detail and effective prioritization.
• Ability to multitask and travel to project sites in various locations.
• Proficiency with Microsoft Office products (Excel, Word, PowerPoint) and strong computer/database skills.
• Experience with CCMS/CMMS (RAM) and training database systems.