Quality Assurance SME

, is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

S. Department of Health and Human Services in Washington, DC. BARDA’s mission is to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their official website.

Responsibilities

include but are not limited to the following. Other duties may be assigned : Serve as a source of general quality guidance and as a technical resource for quality issues and compliance issues. Review and evaluate documentation related to Quality Management Systems, Quality Agreements, quality documents, development plans, development study reports, study protocols.

Review development activities and documentation to ensure products meet specifications, are produced and tested in compliance with approved procedures and applicable regulations/industry standards. Assist in Quality investigations of GMP activities as subject matter expert (SME). Provide assessments of recommended corrective and preventative actions; ensure implementation of corrective and preventative actions.

Audit function: Lead, support, and participate in auditing activities, including supplier audits, contractor audits, manufacturing site audits, and regulatory inspections. Evaluate responses to audit findings for adequacy. Ensure timely and effective close-out of corrective and preventative actions.

Serve as ‘man in the plant’ as required. Support development, organization, maintenance of SOPS, internal quality documentation, files, records and quality databases. Education : BS.

S. in life sciences or related field.

Requirements

: Recognized Quality expert with minimum of 10 years progressive experience in drug development, manufacturing environment with extensive experience in regulatory compliance and auditing in cGMP regulated industry. Skilled in developing, implementing, managing, and integrating Quality Management Systems for drug and biologic development and manufacture.

, is a plus. Experienced in the development of manufacturing processes for drugs and biologics with a strong ability to effectively interact with diverse teams to identify opportunities to improve quality and resolve quality/compliance issues.

regarding cGMP for clinical supplies and final products supported by a broad expert knowledge base in all GXPs. Must be able to interpret and apply regulations and guidance independently with understanding of the approach and perspectives of regulatory agencies.