QA Specialist II - Deviations & CAPAs

KBI Biopharma • Durham, NC

1d

About The Position

The QA Specialists on the Deviations and CAPAs team will provide oversight for ongoing manufacturing operations at a biopharmaceutical manufacturing facility. The individual will report to the QA Manager of Deviations and CAPAs. The individual will be responsible for collaborating with Operations Compliance staff on timely resolution of departures from established standards. The ideal candidate will have experience providing quality oversight and/or supporting compliance activities for a commercial GMP facility. Additionally, experience with single use equipment and an understanding of upstream, downstream and/or manufacturing support biotechnology principles is desired. Willingness to learn by interacting with peers, Operations staff, and individually through document review is required. Must thoroughly grasp and be able to clearly present technical concepts. The Specialist should possess technical writing and problem-solving skills and a drive for continuous improvement. This role will be responsible for collaborating with Operations teams on completion of thorough and robust manufacturing investigations, implementation of effective corrective/preventative actions, and manufacturing change controls. The individual is responsible for working cross-functionally with the Manufacturing, Engineering, Supply Chain, IT, QC and other key departments to ensure manufacturing operations are compliant with GxP requirements. This requires a drive for continuous improvement, simplicity and superior equipment and human performance.

Requirements

• Bachelor’s degree and 3+ years’ experience or Master’s degree and 1+ years’ experience in a QA or cGMP environment in Biopharmaceuticals or equivalent.
• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
• Understanding of FDA, EU and ROW cGMP regulations is required.
• Ability to read, analyze, and interpret, general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and auditors.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Nice To Haves

• Experience providing quality oversight and/or supporting compliance activities for a commercial GMP facility.
• Experience with single use equipment.
• Understanding of upstream, downstream and/or manufacturing support biotechnology principles.
• Technical writing skills.
• Problem-solving skills.
• Drive for continuous improvement.

Responsibilities

• Work directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and compliance issues in a timely manner.
• Support timely review of events for classification, initiation and closure.
• Review and approve Deviations and CAPAs.
• Ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks for Deviations according to cGMP requirements.
• Objectively verify technical accuracy and facts associated with departures from standards contained within Deviation reports.
• Support the generation of metrics, identify trends, and project specific status updates of Deviations and CAPAs.
• Collaborate with functional areas to improve the Deviation/CAPA system, to include support in development of training materials and training personnel.
• Drive responses to Client comments on deviation and CAPA reports.
• Support client audits and regulatory inspections as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level