Sr. Quality Assurance Specialist

Key Responsibilities

Quality System Records (Core Scope)

• Independently conduct, document, and close critical, major, and minor investigations related to facilities, utilities, equipment, instrumentation, calibration, maintenance, and engineering systems.
• Act as the Deviation Investigation Owner for Facilities and Engineering quality records.
• Manage and track Deviation Reports, ensuring timely root cause analysis, impact assessments, and adherence to established due dates.
• Lead, assess, approve, and verify Corrective and Preventive Actions (CAPAs) and associated Effectiveness Checks.
• Coordinate with Quality Assurance to ensure appropriate review, approval, and closure of quality records.
• Initiate, author, and support Change Control Records associated with:
  • Facility modifications and utility system changes
  • Equipment and instrument installation or removal
  • BMS/EMS configuration and firmware updates
  • CMMS asset updates and engineering system integrations
• Maintain and update quality tracking tools and databases; issue reminders and monitor performance against targets.
• Develop, analyze, and present quality system metrics and trending reports for management review; escalate risks and issues as appropriate.
• Demonstrated technical writing experience in biotech or pharmaceutical environments.
• Proven technical literacy sufficient to understand facilities, utilities, MEP, and automation systems in support of GxP quality records.

Investigation Leadership & Technical Problem Solving

• Facilitate cross‑functional meetings with Facilities Operations, Engineering, EHS, Calibration/PM, Automation, Validation, and external vendors to align on investigations and corrective actions.
• Apply structured Root Cause Analysis (RCA) methodologies to identify underlying causes and define sustainable preventive actions.
• Lead investigations ranging from moderately complex to highly complex, including:
  • Single‑system issues
  • Multi‑system or cross‑functional CEF events (e.g., system configuration changes, automation interfaces, data trending, and activities spanning multiple CEF disciplines)
• Provide technical input on engineering and maintenance issues, utility performance, asset reliability, and system configuration integrity.

Documentation & Quality Oversight

• Develop, write, revise, and implement controlled documents (SOPs, specifications, work instructions, templates) supporting Facilities Operations and Engineering.
• Review documentation for accuracy, regulatory compliance, and alignment with operational intent.
• Perform high‑level quality reviews of technical data prior to senior management approval.
• Maintain programs and processes that ensure ongoing compliance with cGMPs and internal quality standards.
• Ensure quality records are clear, concise, complete, and inspection‑ready.

Compliance, Audits & Inspection Support

• Support regulatory inspections and serve as an SME for Facilities, Utilities, Equipment, and Engineering Systems.
• Support internal and external audits, including preparation of documentation and written responses.
• Provide interpretation and guidance on cGMP, FDA, EU, and ICH regulations applicable to facilities and engineering systems.
• Maintain current knowledge of compliance requirements through training and participation in industry forums.

Operational & Project Responsibilities

• Identify gaps or inefficiencies in existing processes and collaborate with peers and leadership to implement improvements.
• Exercise sound judgment within established practices to select appropriate methods and evaluation criteria.
• Manage multiple priorities simultaneously while maintaining high‑quality output.
• Support projects and quality events by owning and driving associated GxP quality records (deviations, investigations, CAPAs, change controls).
• Coordinate and integrate inputs from subject matter experts to support timely and compliant record closure.

Management & Cross‑Functional Leadership

• Provide coordination and work direction as needed (e.g., aligning SMEs on inputs, timelines, and deliverables for GxP quality records) without formal people‑management responsibility.
• Lead smaller, tactical initiatives related to quality records or process improvements within the department.
• Serve as the CEF Quality point of contact on cross‑functional initiatives in close partnership with the Quality organization.
• Function as the primary Quality liaison for Facilities and Engineering operations.

Knowledge & Skills

• Strong proficiency in cGMPs and Quality Assurance system principles, concepts, and industry best practices.
• Solid working knowledge of biotech/pharmaceutical facilities, utilities, equipment, and instrumentation in regulated GxP environments.
• Proficiency in Root Cause Analysis, Six Sigma/Lean tools, and risk management methodologies (e.g., HACCP, FMEA).
• Strong audit, investigation, and technical writing skills.
• Excellent communication, interpersonal, and organizational skills, with the ability to explain complex concepts clearly.
• Proficiency in Microsoft Office and Bluebeam; familiarity with EDMS, CMMS, QMS, and other GxP systems preferred.
• Ability to work under tight deadlines and manage competing priorities.
• Experience reading and interpreting facility drawings (P&IDs, floor plans).
• Working knowledge of commissioning and validation activities.

Basic Qualifications

• Bachelor’s degree in a technical or scientific discipline with 6+ years of direct experience in the pharmaceutical or life‑science industry, OR
• Master’s degree with 4+ years of direct industry experience.

OR

• Bachelor’s degree with 6+ years of experience in a GMP‑regulated environment, OR
• Master’s degree with 4+ years of GMP‑regulated experience.

Preferred Qualifications

• Experience using GxP electronic systems, including EDMS, CMMS, and QMS platforms.