Specialist QA

Under minimal supervision, the Quality Assurance (QA) Specialist supports and executes key activities within the Quality Assurance program to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal procedures.

This role provides quality oversight across manufacturing, validation, facilities, and quality systems, while supporting investigations, audits, change control, and product disposition. The QA Specialist may represent QA in cross-functional teams and serve as a delegate for QA leadership when required.

Key Responsibilities

• Provide QA oversight to ensure manufacturing, testing, storage, and distribution activities comply with cGMP, cGLP, and applicable regulations.
• Perform lot disposition and authorize product release for shipment.
• Review and approve manufacturing production records (MPs).
• Ensure production records and test results are complete, accurate, and compliant.
• Evaluate compliance issues and escalate risks to senior management.
• Review and approve:
• Non-conformance (NC) investigations and CAPA records
• Change controls
• Risk assessments
• Planned incidents

• Lead and support deviation investigations, ensuring timely closure.
• Participate in incident triage teams.
• Ensure deviations and changes are properly documented and assessed.
• Review and approve process validation protocols and reports.
• Approve Environmental Characterization reports.
• Support computer system validation (CSV) and automation-related quality activities.
• Review and approve EMS/BMS alarms and Work Orders.
• Release sanitary utility systems.
• Support facilities, environmental, and monitoring programs.
• Ensure alignment of equipment, systems, and processes with regulatory expectations.
• Represent QA on NPI teams.
• Provide QA oversight for new processes, equipment, and product introductions.
• Support automation and cross-functional projects.
• Champion continuous improvement initiatives.
• Lead and participate in site audits and regulatory inspections.
• Serve as QA representative during internal and external audits.
• Interface with regulatory agencies as required.
• Own and maintain site Quality Program procedures.
• Act as designee for QA Manager on local CCRB (Change Control Review Board).
• Lead cross-functional teams and influence stakeholders across departments.

Required Skills & Competencies

• Strong knowledge of cGMP regulations and Quality Systems.
• Experience in manufacturing, QA, validation, and process development.
• Advanced investigation, root cause analysis, and problem-solving skills.
• Strong project management and organizational skills.
• Ability to lead, influence, and negotiate across cross-functional teams.
• Strong communication, technical writing, and presentation skills.
• Ability to work independently and manage multiple priorities.
• Advanced data trending and analysis capabilities.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, databases).

Requirements:
• Doctorate degree, OR

• Master’s degree + 2 years of Quality or Manufacturing support experience in a GMP-regulated pharmaceutical environment, OR
• Bachelor’s degree + 4 years of relevant experience, OR
• Associate’s degree + 8 years of relevant experience, OR
• High School Diploma/GED + 10 years of relevant experience

Preferred Qualifications

• Educational background in Life Sciences or Engineering.
• Extensive experience with Quality Systems:
• Deviations (Non-conformances)
• CAPA
• Change Control

• Hands-on experience with systems such as:
• TrackWise, Veeva, LIMS, MES, SAP, Maximo, CDOCS

• Experience in Computer System Validation (CSV) and GxP applications.
• Knowledge of validation lifecycle:
• Validation Master Plans (VMP)
• Risk Assessments
• IQ/OQ/PQ protocols and reports

• Experience supporting:
• Packaging, inspection, commissioning, and qualification projects

• Demonstrated ability to:
• Lead audits and regulatory interactions
• Manage complex projects and competing priorities
• Drive continuous improvement initiatives

• Strong bilingual communication skills (English & Spanish preferred).
• Ability to effectively collaborate across all organizational levels, including remote teams.

Benefits:
• 6-month contract position
• Non-Standard Shift-Night Shift: 5:00pm-5:30AM