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
...new industry? If the answer is yes, we are looking for you! Jump-start your career by joining our growing team as an entry-level insurance agent. Candidates with strong interpersonal communication skills will hit the ground running to facilitate insurance sales among...
...Dynamic Transportation and Logistics is a Third-Party Delivery Contractor known for its exceptional delivery performance operating out of 9155 Derrington Road. As a Delivery Associate with us, you will play a crucial role in ensuring customers receive their orders...
...HOMES Brewery is a microbrewery in Ann Arbor, MI, specializing in IPAs and fruited sours paired with Asian-inspired street food. Over... ...interested in tackling exciting new challenges in the world of craft beer. Our ideal candidate is a natural people person, loves guest...
Join Our Team as a Non-Medical Transportation Driver! Are you a reliable and compassionate driver looking to make a difference in your community? Elite Day Centers is seeking Non-Medical Transportation Drivers to safely transport our members to and from our centers and...
The Social Media Manager (SMM) is the social media lead for Texas Lifestyle Magazine (TLM). The primary responsibility is to make sure content is being posted consistently on the TLM platforms based on the strategy developed by the Social Media Manager and the TLM leadership...