Quality Assurance Specialist (Onsite – 8-Month Project | 3rd Shift)

Position Summary

The Quality Assurance Specialist provides oversight and ensures compliance of manufacturing, testing, and release activities for pharmaceutical drug substances (API). This role is responsible for maintaining adherence to cGMP, cGLP, and applicable regulatory requirements while supporting Quality Systems and cross-functional operations.

The position requires strong technical expertise, attention to detail, and the ability to work independently in a fast-paced manufacturing environment.

Assignment Details

• Location: Onsite
• Duration: 8-month project
• Shift: 3rd Shift (10:00 PM – 6:30 AM)

Key Responsibilities

• Execute Quality disposition activities (approval or rejection) for bulk drug substances.
• Provide Quality oversight to ensure manufacturing, testing, storage, and handling activities comply with cGMP, cGLP, and applicable regulations.
• Ensure deviations from established procedures are identified, documented, and investigated in accordance with Quality Systems requirements.
• Evaluate and ensure proper assessment of changes that may impact product quality through Change Control processes.
• Review production records and laboratory results for completeness, accuracy, and compliance with cGMP standards.
• Ensure facilities, equipment, materials, processes, and procedures meet regulatory and compliance expectations.
• Champion and support continuous improvement initiatives, including efficiency and compliance enhancement projects.
• Maintain training compliance and ensure readiness to perform assigned responsibilities.
• Collaborate cross-functionally to ensure Quality Management System (QMS) processes are executed effectively.
• Support internal and external audits and regulatory inspections, serving as Quality Unit representative as required.
• Escalate quality, compliance, supply, and safety risks to senior management as needed.
• Provide Quality support and oversight for New Product Introductions (NPI).

Preferred Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
• Strong experience in Quality Systems, including Deviations (Non-Conformances), CAPA, and Change Control.
• Experience with electronic systems such as CDOCS (or similar documentation systems), Maximo, TrackWise, LIMS, MES/electronic batch records, and SAP.
• Experience in Computer Systems Validation (CSV) or Computer Systems Quality Assurance.
• Knowledge of validation lifecycle activities, including Validation Master Plans, risk assessments, IQ/OQ/PQ protocols, test scripts, and validation reports.
• Solid understanding of manufacturing and distribution processes, including QA, QC, and Process Development.
• Experience supporting complex projects (e.g., packaging, inspection, commissioning, qualification, and NPI).
• Strong organizational and project management skills with the ability to drive tasks to completion.
• Demonstrated leadership, influencing, and problem-solving abilities.
• Experience interacting with regulatory agencies and addressing compliance-related issues.
• Excellent written and verbal communication skills.
• Fully bilingual (English/Spanish) preferred.
• Ability to work independently and effectively across all organizational levels.

Additional Notes

• Flexibility to support extended hours or additional shifts as required by business needs.
• Other duties may be assigned based on project requirements.