Quality Assurance Engineer

Company Info
Radnor, PA, United States

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Company Profile


Quality Assurance Engineer


Saint Louis, MO 

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Job Description:

 Under limited direction, direct the activities for the quality organization for their respective facility. Manage, organize, oversee, and ensure the objectives of the QA/QC function are implemented in line with Corporate, site quality and business goals. Develop, manage, and maintain the quality management system to meet applicable regulatory requirements (FDA CFRs, U.S, and international regulations) and international quality standards; ensure products meet customer quality expectations and requirements. Develop, monitor, and manage approved departmental budget. Ensure timely closure of all non-conformances, failure investigation reports and corrective/preventive actions; develop strategies for continuous improvement. 


  • Oversee writing, revision, implementation and training of standard operating procedures and work instructions.
  • Ensures Quality System Requirements are met.
  • Identify staff development needs in area such as training, technical skills, and safety.
  • Communicate with customers with customers regarding quality related issues and complaints.
  • Review test results for raw material, in-process, and final product samples.
  • Evaluate and implement new test methods as appropriate.
  • Interpret and apply evolving regulatory and Quality standards.
  • Interact as required with supply partners: raw materials and testing
  • Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests.
  • Responsible for Batch review and approval, C of A creation, and CAPA process.
  • Provide technical and quality operations support to other departments and contract manufacturers.
  • Drive efficiency, practices and policies that improve quality.
  • Analyze trends to improve quality and allocate resources to drive continuous improvement.
  • Provide direction to Process Engineers, prioritizing projects, assigning tasks, establishing completion dates, and ensuring projects are completed on time.
  • Review processing documentation/records
  • Represent Avantor during Customer Audits. Coordinate timely responses to customer audit findings.
  • Investigate and ensure appropriate root cause analysis is performed and effective CAPA implemented in response to Customer Complaints.
  • Experience with Document Control system within the EtQ system.
  • Establish Non-Disclosure Agreements in conjunction with Avantor legal to support business needs.
  • Assist the Sales team by maintaining and revising product specifications as directed.
  • Provide leadership and mentorship to the quality team.
  • Performs other duties as assigned.


  • BS degree in a scientific discipline such as engineering, chemistry, biochemistry preferred
  • 5+ years of applicable work experience preferred
  • 3+ years’ experience in chemical manufacturing and pharmaceutical industry preferred
  • 3+ years’ experience in quality, auditing and/or project management preferred
  • Demonstrated experience and working knowledge of cGMPs and associated guidelines regulatory guidelines for the manufacture, testing and release of serum related products
  • Ability to work successfully both independently and in a team environment
  • CQA or CQE certification preferred


  • Strong written and verbal communication skills
  • Strong analytical skills
  • Advanced skills in MS Office products including Excel, Visio, and PowerPoint
  • Ability to lead cross functional teams to execute on complex tasks in a growing and changing environment
  • Knowledge and skills in root cause analysis and the CAPA process
  • Demonstrated working with integrity and intensity
  • Demonstrated entrepreneurial capability while working within a large company


Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.

Ability to work in a regulated laboratory/production environment as required.

Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.

Travel may be required; should not exceed 15% of time.

A frequent volume of work and deadlines impose strain on routine basis.

Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs