Job Summary:

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.

Job 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.

Minimum Requirements:

Knowledge, Skills, Abilities

• 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.

Language Ability

• 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.

Reasoning Ability

• 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.

Math Ability

• Basic math skills are required.
• Ability to apply concepts of basic algebra and statistics.

Physical Demands

• Be able to sit for long periods of time.
• Be able to lift 20 pounds.

Computer Skills

• Knowledge of and experience using word processing, databases, spreadsheets, PowerPoint, Excel, internet, e-mail, calendar management, Teams and Sharepoint.

Equipment Use

• Knowledge of and experience using a computer, and a telephone

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.