Quality Assurance Associate III Job at Medix, Allendale, NJ

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  • Medix
  • Allendale, NJ

Job Description

Quality Assurance Associate III - 244917
Responsibilities
  • On-site role providing QA oversight for manufacturing operations.
  • Review and approve deviations, non-conformance events, change requests, and change controls.
  • Audit and approve pre-/post-executed batch records, validation reports, and product/label specifications in compliance with cGMP and internal procedures.
  • Prepare release checklists, CoAs, and related documentation to support timely batch disposition.
  • Serve as QA liaison with manufacturing, project teams, clients, and regulatory bodies, ensuring quality standards are met and issues are appropriately escalated.
  • Write, review, and revise SOPs; lead/participate in audits, inspections, walkthroughs, and process improvement initiatives.
  • Represent QA in meetings and act as the single point of contact for designated clients.
  • May perform qualified visual inspections of final product when required.
Education & Experience
  • 5+ years of experience in the biopharmaceutical industry
  • Bachelors degree in a Science related field preferred
Knowledge, Skills & Abilities
  • Strong knowledge of FDA/EU cGMP requirements and QA documentation practices.
  • Proficient with Microsoft Office; able to perform accurate calculations and data recording.
  • Experienced in reviewing/approving deviations, NCEs, and change controls.
  • Skilled in problem-solving, decision-making, and prioritizing competing tasks.
  • Effective communicator with strong interpersonal and teamwork abilities.
  • Flexible and adaptable to changing priorities and business needs.
  • Demonstrated ability to work independently on complex issues while building productive internal/external relationships.
Seniority level
  • Associate
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Biotechnology Research and Pharmaceutical Manufacturing

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Job Tags

Full time, Work at office, Flexible hours,

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