Primary role:

Quality Assurance (QA) for current Good Manufacturing Practice (cGMP)-compliant programs is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. With minimal management oversight and by working independently, the QA Contractor will perform a variety of duties associated with the Office of Regulatory Affairs and Quality in support of the cGMP programs at Client, including critical review of GMP analytical in-process, release, and stability data and critical review of deviations and investigations;. This position will consult with GMP Analytical Development staff, as applicable/requested, to serve as a resource. This position reports directly to the CGMP Program (DGP) Director of the Quality Systems Unit (QSU).

Essential tasks/responsibilities:

With minimal direct oversight:

·      Perform quality-focused reviews of GMP Analytical and QC Data review (75%)

o  Perform detailed review of GMP analytical test records for compliance to internal SOPs/test methods, Good Documentation Practices, data integrity standards, general GMP expectations, and critical thinking to ensure compliance and accuracy.

o  Compose and review Certificates of Analysis and Certificates of Testing with minimal re-work and a high percentage of “right first time”

o  Assist with the identification and implementation of process improvements to data review processes

·      Assist with final quality review of manufacturing/analytical deviations and associated CAPAs (20%)

o  Identify, escalate, and assist in investigating documentation inconsistencies, data integrity concerns, deviations, and out-of-specifications

o  Ensure completeness and thoroughness of investigations, root cause analysis, and impact assessments

o  Provide critical review and feedback to staff completing deviation stages and performing quality review of deviation/CAPA reports

·      Participate in other quality roles/responsibilities (5%)

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Education/training:

Required: Bachelor’s degree

Preferred: Master’s or doctorate-level degree

Experience:

Required: 5 years of experience in GMP quality or quality control, preferably related to analytical release/stability testing under GMP. Experience in early clinical phase vaccine manufacturing a plus.

Preferred:

·      Close attention to detail and ability to format documents consistently

·      Experience in Microsoft Office applications, including Word and Excel

·      Experience in deviation/CAPA management and RCA

·      Experience in document management/review

·      Experience in cGMP manufacturing/analytical processes

OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE             

Skills:

Required:

•      Working knowledge of GMP

•      Organizational and time management skills with the ability to handle a multitude of tasks.

•      Working knowledge of electronic databases.

•      Ability to pay close attention to detail and ensure consistency of documents

•      Ability to work independently or in a team environment

•      Excellent verbal, written, and interpersonal skills conducive to interactions with team members at all levels.

•      Possess good problem-solving skills and strong attention to detail/critical thinking skills with demonstrated successes in these areas. High level of accuracy in reviewing large volumes of complex analytical data.

Special competencies/credentials:

Required: None

           Preferred: None

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description