Sr. Quality Assurance Specialist

• 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.

• Facilitate crossfunctional 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:
  • Singlesystem issues
  • Multisystem or crossfunctional 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.

• 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 highlevel 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 inspectionready.

• 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.

• 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 highquality 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.

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

• 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.

• Bachelors degree in a technical or scientific discipline with 6 years of direct experience in the pharmaceutical or lifescience industry OR
• Masters degree with 4 years of direct industry experience.

OR

• Bachelors degree with 6 years of experience in a GMPregulated environment OR
• Masters degree with 4 years of GMPregulated experience.

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