CMO Quality Assurance Engineer Job at Stark Pharma Solutions Inc, Pennsylvania

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  • Stark Pharma Solutions Inc
  • Pennsylvania

Job Description

Position: CMO Quality Assurance Engineer (Packaging & Labeling Final Drug Product)
Location: Philadelphia, PA
Level: Senior
Employment Type: Contract

Position Summary

We are seeking an experienced Quality Assurance Engineer with specialized knowledge in the packaging and labeling of final drug products to support Contract Manufacturing Organization (CMO) operations. This senior-level role is responsible for overseeing quality systems, managing deviations, ensuring compliance with regulatory requirements, and providing leadership within a dynamic, GMP-compliant manufacturing environment.

Key Responsibilities
  • Develop, implement, and maintain robust quality systems, including change control, deviation handling, CAPAs, and investigations.

  • Conduct and support audits to ensure CMOs comply with cGMP, FDA regulations, internal quality standards, and client-specific requirements.

  • Investigate and resolve deviations, OOS (Out-of-Specification) results, and other quality-related issues at the CMO site.

  • Review and approve change requests related to manufacturing processes, materials, equipment, and labeling/packaging components.

  • Review and approve batch production and packaging records to ensure product quality before release.

  • Ensure clear, consistent communication between internal stakeholders and CMO partners.

  • Monitor and ensure CMO compliance with applicable regulatory guidelines and internal policies.

  • Track, analyze, and report key quality performance indicators to identify risks, drive improvements, and support quality oversight.

  • Perform additional responsibilities and tasks as assigned by QA management.

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, or a related technical field.

  • Minimum of 10 years of experience in a GMP-regulated pharmaceutical manufacturing environment, with a strong background in Quality Assurance.

  • In-depth knowledge of FDA regulations, cGMP, and industry best practices.

  • Proven experience in quality oversight of CMOs, specifically in drug product packaging and labeling.

  • Strong critical thinking, problem-solving, and technical writing skills.

  • Excellent organizational, interpersonal, and communication skills.

  • Ability to work independently and collaboratively in a cross-functional environment.

Note: Travel to CMO sites may be required based on project needs.

Job Tags

Contract work,

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