KBI: US - Principal QA Specialist - Product Support

KBI Biopharma • Durham, NC

52d

About The Position

Responsible for providing Quality Assurance support to Manufacturing Process Operations. Performs document review and approval of Master Batch Records, SOP's and Technical Documents. Collaborate directly with MS&T and Manufacturing to support BOM review and approvals to meet timelines.

Requirements

• BS and 10+ years' experience or equivalent or MS and 8+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
• Experience in a QA role supporting Manufacturing Process Operations and validations is required.
• Knowledge of US, EU and cGMP guidelines is required.
• Working knowledge of electronical management systems,
• Operational Excellence tools and ERP systems is desired.
• 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 the general public.
• 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.
• Basic math skills are required.
• Ability to apply concepts of basic algebra and statistics.
• Be able to sit for long periods of time.
• Be able to lift 20 pounds.
• Knowledge of and experience using word processing, databases, spreadsheets, PowerPoint, Excel, internet, e-mail, calendar management, Teams and Sharepoint.

Responsibilities

• Supports BOM review, approval, and release within ERP system
• Reviews and approves Technical Documents associated with process validation and manufacturing operations, including but not limited to the following document types: Process Characterization, Process Performance Qualification, Resin and Membrane Qualifications, and Non-routine Sample Plans.
• Provides general QA support to manufacturing operations, which includes deviation investigations, CAPAs, procedures and change control assessments, as required.
• Performs compliance review of executed batch records and internal support records, as needed.
• Attend relevant project and operational meetings. Support client audits, client meetings, regulatory inspections, and process improvement projects, as required.
• Supports training and mentoring of other Quality department staff to perform quality duties, as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 1,001-5,000 employees