Summary

The Quality Assurance Specialist is responsible for providing
Quality oversight and ensuring compliance
with current Good Manufacturing Practices (
cGMP
), Good Laboratory Practices (
cGLP
), and applicable regulatory requirements for clinical and commercial drug substance (
API
) operations. This role supports manufacturing,
quality systems
,
audits
, and new product introductions (
NPI
) while
promoting compliance and continuous improvement
.

Responsibilities

• 
  Execute Quality disposition (approval or rejection) of bulk drug substances.
• 
  Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
• 
  Ensure that deviations from established procedures are identified, reported, and documented per procedures.
• 
  Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
• 
  Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• 
  Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
• 
  Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
• 
  Ensure completion of required training and maintain assigned training adherence to support successful task execution.
• 
  Collaborate and partner cross-functionally to ensure that Quality Management System (QMS) processes are completed in accordance with established procedures.
• 
  Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
• 
  Alert senior management of quality, compliance, supply, and safety risks.
• 
  Provide support and oversight for New Product Introduction (NPI).

Requirements

• 
  Educational background in Life Sciences and/or Engineering.
• 
  Expertise in
  Quality Systems
  , including Deviations (Non-Conformities),
  CAPA
  , and
  Change Control
  .
• 
  Experience with key electronic systems, such as
  documentation platforms
  (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
• 
  Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting-level technical proficiency.
• 
  Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
• 
  Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
• 
  Validated experience serving as quality contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
• 
  Strong organizational skills, with the ability to drive assignments through successful completion.
• 
  Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
• 
  Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.