QA Specialist II - Deviations & CAPAs

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a QA Specialist for the Deviations and CAPAs team to oversee GMP manufacturing operations at our Durham facility.

The role collaborates with Operations Compliance and other functions to resolve deviations, classify events, and ensure robust investigations and CAPAs. Candidates should have a Bachelor's degree with 3+ years in QA or cGMP in biopharma, or a Master's with 1+ year.

Qualifications

• Bachelor’s degree with 3+ years’ QA or cGMP in biopharma, or Master’s with 1+ year.
• Strong interpersonal skills and ability to present technical concepts clearly.
• Ability to read, analyze, and interpret regulatory documents and procedures.
• Willingness to collaborate with multiple departments to ensure compliance.

Responsibilities

• Resolve production deviations and compliance issues in a timely manner.
• Review, classify, and close events; prepare RCA and CAPA documentation.
• Approve Deviations and CAPAs; track effectiveness checks.
• Support client audits and regulatory inspections as required.

Skills

QA experience

cGMP knowledge

cross-functional collaboration

technical writing

problem-solving

Education

Bachelor’s degree with 3+ years QA

Master’s degree with 1+ year QA

Job description

Position Summary 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.

Position 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.

Position 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.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.