KBI: US - Principal QA Specialist

KBI Biopharma • Durham, NC

3d • Onsite

About The Position

This individual is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review and approval of in-process, release, and stability test data. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with clients, laboratories, manufacturing, QA batch disposition and other internal stakeholders as needed to achieve site, operational and department specific goals. Cultivates and maintains Quality culture. May perform as a team lead for a specific responsibility listed below, in which case, the Approximated amount of time will be skewed toward the specific responsibility.

Requirements

• Bachelor’s degree and 10+ years’ experience or Master’s degree and 6+ years’ experience in a QA, QC 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.
• Strong understanding of FDA, EU and cGMP regulations is required.

Nice To Haves

• Experience in Quality Control and Quality Systems is beneficial.

Responsibilities

• Performs timely review of test data for in process, release, and stability samples.
• Assures activities comply with required procedures, cGLP, and cGMP requirements.
• Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability testing.
• Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs.
• Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities.
• Supports client audits and regulatory inspections as required.
• Other activities as assigned by Management.
• Provides QA oversight of special projects such as implementation of new processes to support site, operational and department goals.
• Serves as trainer/mentor for QA Specialists and cross-trainer for employees in other departments to support individual development goals.

What This Job Offers

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