Specialist Quality Assurance - Drug Substance

We are seeking a Specialist Quality Assurance to provide on-the-floor Plant Quality Assurance (PQA) support for Drug Substance operations at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. This role ensures that manufacturing processes, records and changes meet cGMP requirements and site procedures, and partners closely with Manufacturing, Process Development, Validation, Quality Control and Engineering.

Key Responsibilities

• Perform on-the-floor PQA review, approval and tracking of cGMP processes, procedures, documents and records, including batch record review in MES/EBR, SAP and electronic quality systems.
• Ensure on-the-floor triage of deviations is completed and documented, and that deviations are investigated per procedure.
• Ensure changes potentially impacting product quality are assessed according to procedures.
• Ensure production records and testing results are complete, accurate and documented per cGMP requirements.
• Support internal and external audits and inspections, acting as Quality unit representative as needed.
• Provide Quality support and oversight for New Product Introduction (NPI) and serve as Quality contact for complex projects.
• Review and approve validation deliverables for GxP applications and equipment (VMP, IQ/OQ/PQ, risk assessments, test scripts and summary reports).
• Champion continuous improvement initiatives and projects.

Requirements

• Education
• Bachelor's degree in Science or Engineering + 4 years of directly related experience

Preferred Qualifications

• Demonstrated expertise in Quality Systems such as deviations, CAPA and change control
• Experience in computer systems validation or computer systems quality assurance
• Experience in commissioning and qualification and validation of GxP applications
• Strong knowledge of manufacturing, distribution, QA and Process Development processes
• Experience with MES, EBR, SAP and Trackwise or similar systems
• Key Skills
• Strong communication skills in English and Spanish (written and oral), facilitation and presentation skills
• Strong organizational skills; enhanced leading, influencing and negotiating skills
• Ability to interact effectively with regulatory agencies
• Advanced data trending and evaluation; ability to evaluate compliance issues
• Able to work independently and interact effectively at all levels of the organization