Specialist QA

Under minimal supervision, the Specialist QA supports the site Quality Assurance program by ensuring compliance with cGMP requirements, regulatory standards, and internal quality systems. The role provides oversight across manufacturing, environmental monitoring, critical utilities, validation, and quality systems, while driving continuous improvement and maintaining a strong contamination control posture.

FUNCTIONS

• Review and approve product MPs, process validation protocols, and validation reports.
• Review and approve Work Orders, EMS/BMS alarms, nonconformance investigations, CAPA records, and change controls.
• Approve Environmental Characterization reports and planned incidents.
• Provide lot disposition and authorize lots for shipment.
• Lead investigations, site audits, and own site quality program procedures.
• Serve as QA designee on local CCRB and represent QA on NPI teams.
• Participate in incident triage teams and support automation, facilities, and environmental programs.
• Review and assess risk assessments across GMP operations.
• Ensure facilities, equipment, materials, processes, and products comply with cGMP and applicable regulations.
• Support internal and external audits and inspections.
• Alert senior management of quality, compliance, supply, and safety risks.
• Support GMP building Environmental Monitoring (EM) processes.
• Generate EM and Critical Utilities (CU) trend reports; analyze data to identify improvement opportunities.
• Lead or participate in risk assessments for sampling sites in GMP areas.
• Provide quality assessments for change controls, deviations, audits, and contamination control initiatives.
• Participate in Environmental Control Network, Aseptic Council, and Contamination Control Network.
• Present EM/CU data and recommendations during Quality System forums and Management Review meetings.
• Ensure adherence to regulatory standards including Annex 1, FDA Guidance, ISO‑14644‑1, and USP.
• Support continuous improvement initiatives related to contamination control and environmental programs.

COMPETENCIES & SKILLS

• Strong knowledge of QA, QAL, validation, process development, and GMP manufacturing.
• Advanced data trending, evaluation, and compliance issue assessment.
• Experience in EM, Microbial Identification, CU monitoring, sampling techniques, and microbiological testing methods.
• Understanding of aseptic behavior, facility cleaning/disinfection, and contamination control strategies.
• Ability to interpret and apply regulatory requirements for cleanrooms and controlled environments.
• Proficiency in Microsoft Office (Word, PowerPoint, Excel), Smartsheets, and data visualization tools.
• Hands-on experience with electronic systems such as Veeva, Spotfire, LIMS, Maximo.
• Ability to use statistical tools and AI/data analytics platforms to interpret EM/CU data.
• Strong project management and organizational skills.
• Ability to lead cross-functional teams, influence stakeholders, and negotiate effectively.
• Strong written and oral communication skills; facilitation and presentation capabilities.
• Fully bilingual in English and Spanish.
• Demonstrated ability to interact with regulatory agencies.
• Ability to work independently and collaborate across multiple levels of the organization.
• Demonstrates strong leadership practices and quality mindset.

EDUCATION REQUIREMENTS

• Doctorate OR
• Master’s + 2 years directly related experience OR
• Bachelor’s + 4 years directly related experience OR
• Associate’s + 8 years directly related experience OR
• High School/GED + 10 years directly related experience

Preferred:

• Bachelor’s or higher in Microbiology, Biology, Life Sciences, Engineering, Chemistry, Physics, or Computer Science.
• 10+ years in biopharmaceutical industry with 5+ years in Quality.

PREFERRED QUALIFICATIONS

• Extensive experience in Quality & Compliance, regulatory audits, validation, characterization, and automation validation.
• Strong background in reviewing/approving deviations, EM/CU trend reports, and contamination control documentation.
• Ability to identify quality, compliance, supply, and safety risks and escalate appropriately.

• Administrative Shift
• 1 Year contract