Quality Assurance Engineer External Manufacturing

The Quality Assurance Engineer shall be responsible for providing overall Quality Assurance support in the management of external (contract) manufacturing sites engaged in the production of Pharmaceutical Products.

Under minimal supervision, the QE shall support activities at established external manufacturing sites via the following:

• Review and approve First Article of Inspection (FAI)
• Create, Review and Approve Product Specs
• Review batch records for batch release
• Reports, tracks, and follows up on deficiencies noted at external manufacturing sites, including assessments, audits, investigations, and overall site performance.
• Lead the remediation of Quality process issues with the external manufacturing site
• Proactive participation on new product development teams, including coordination with Technical Transfer team, to ensure that all projects meet specified QA launch requirements and timelines.
• Guidance and review in the development of APR and change control documentation for new product launches and commercialized products, respectively.
• Review of specifications and validation documentation related to base business projects and new product introductions.
• Guidance in the implementation of compliance and quality improvement initiatives at external manufacturing sites, during product development, scale-up, validation, and launch.
• Routine interaction with internal business partners and external manufacturing sites, in support of commercialization and documentation readiness.
• Compliance with processes and controls, as well as with cGMP and FDA guidelines, to ensure that product quality and performance conform to established standards.
• Troubleshoots quality problems, provides thorough and practical assistance in the resolution of process / product non-conformance events, and assists in the development of corrective actions to prevent reoccurrence, leveraging Quality Systems.
• Drives resolution of consumer complaints through quality investigations and root cause analysis.
• Develops processes and procedures and delivers training in quality-related subjects to the QA division partner functions, business partners, licensees, and external manufacturing sites.
• Administers domestic consumer brand product release program and effectively communicates significant problems or delays to supply chain personnel.
• Additional responsibilities may include:
  • Follow-up on internal and external compliance audit management action plans (MAPs).
  • Review of process / product-related documentation
  • Generation and issuance of Quality Responsibility Agreements
  • Other duties as assigned.

Requirements

Preferred experience:

• QA Experience in the Pharmaceutical or Personal Care industry
• Understanding of Regulatory requirements
• Experience in a GMP facility a must; deep knowledge of FDO regulations

Benefits

A comprehensive benefits package which includes medical, dental, vision, disability and life insurance, 401k and a generous PTO Policy.

About Endeavor:

At Endeavor Consulting Group, our mission is to provide straightforward solutions to complicated situations. As a specialty project management technology and integration firm, we are laser focused on Operational Systems, Supply Chain Integration, and Product Development for Life Sciences enterprises. Our team is driven, energetic, and passionate about delivering results and earning the trust of our ever-expanding client base.

We are dedicated to building a thriving company culture and a workplace environment that fosters respect, honesty, and creativity. Our goal is to help our clients triumph; to do that, we must remain fiercely committed to ensuring the happiness and fulfillment of our employees. In pursuit of excellence, we look for individuals with a customer-focused approach to problem-solving, a desire to exceed expectations, a philanthropic point of view, a dedication to quality service, and a strong technological background.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We are committed to providing accommodation for employees with disabilities.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Want to learn more?

• Check out our