Job Title: CMO Quality Assurance Engineer
Location: Philadelphia, PA
Experience Required: 10 - 12 years
Job Summary:
We are actively seeking an experienced CMO Quality Assurance Engineer to support the packaging and labeling of final drug products. This is a senior-level role with leadership responsibilities in a fast-paced, GMP-compliant manufacturing environment.
Key Responsibilities:
Oversee quality systems, including deviations, change controls, and investigations
Conduct and support audits to ensure compliance with regulatory and client-specific requirements
Manage and resolve deviations, out-of-specification (OOS) results, and other quality issues at the CMO
Review and approve manufacturing changes and batch records to ensure product quality
Ensure full compliance with FDA regulations and current Good Manufacturing Practices (cGMP)
Track and report key quality metrics, and identify opportunities for performance improvement
Collaborate effectively with internal cross-functional teams and external partners
Required Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related field
10+ years of experience in GMP manufacturing (Quality Assurance or Production)
Strong understanding of FDA regulations and cGMP guidelines
Proven ability in technical writing, effective communication, and critical thinking
Prior experience working with Contract Manufacturing Organizations (CMOs)
Experience with final drug product packaging and labeling is highly preferred
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