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

About the role

The Quality Assurance Specialist will provide oversight and ensure compliance of manufacturing, testing, and release activities for pharmaceutical drug substances (API) on a third‑shift, 8‑month onsite project. The role supports cGMP, cGLP and regulatory requirements while driving continuous improvement in a fast‑paced environment.

Key responsibilities

• Execute quality disposition decisions for bulk drug substances, approving or rejecting batches.
• Provide quality oversight of manufacturing, testing, storage and handling to ensure cGMP/cGLP compliance.
• Identify, document and investigate deviations in line with Quality Systems.
• Assess and manage changes impacting product quality through Change Control.
• Review production records and laboratory results for completeness and regulatory compliance.
• Support internal and external audits and act as Quality Unit representative during inspections.
• Champion continuous‑improvement initiatives and support new product introductions.
• Maintain training compliance and collaborate cross‑functionally to execute QMS processes.

Required profile

• Bachelor’s degree in Life Sciences, Engineering or related field (advanced degree preferred).
• Strong experience with Quality Systems, including deviations, CAPA and Change Control.
• Experience supporting complex pharmaceutical projects and new product introductions.
• Demonstrated organizational, project‑management and problem‑solving abilities.

Required skills

• Proficiency with electronic documentation systems such as CDOCS (or similar), Maximo, TrackWise, LIMS and MES/e‑batch records.
• Experience with SAP.
• Knowledge of Computer Systems Validation (CSV) and validation lifecycle activities (Validation Master Plans, risk assessments, IQ/OQ/PQ protocols, test scripts, validation reports).