Job Description

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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