Quality Assurance Supervisor/Sr. Supervisor – QA Analytical

Job Summary:

This position is primarily responsible for supervising a staff that supports the coordination, tracking and review of Test Sample Plans (TSPs) and the associated in-process data associated with batches manufactured at KBI. This position is also responsible for the review and approval of release and stability test data as needed. Experience in the review and approval of laboratory investigations and deviations is also beneficial to this position

Responsibility:

1) Responsible for the coordination and tracking of test sample plans(TSPs) and associated in process data. Report out metrics to relevant operational meetings and/or client meetings. (15%)

2) Perform compliance review of test sample plans and associated in-process data. (55%)

3) Supervises direct reports providing coaching and mentoring. (5%)

4) Develop and/or support training materials for QA review of Test Sample Plans. (5%)

5) Work with functional areas to improve the lifecycle of Test Sample Plan review cycle times and batch release dates. (5%)

6) Responsible for the review of release and stability data as needed. (5%)

7) Responsible for the review and approval of laboratory investigations, deviations, and CAPAs. (5%) 8) Attend relevant operational meetings in support of disposition activities. Support Client Audits and Regulatory Inspections as required. (5%)

Minimum Requirements:

1) Knowledge, Skills, Abilities:

BS in scientific field with 15+ years’ experience or MS and 10+ years’ experience in a QA cGMP regulated environment within biopharmaceuticals or equivalent. Experience with quality systems to include batch release review, batch disposition of biopharmaceuticals, and lab investigations and deviations. Knowledge of US and EU guidelines is a plus.

2) 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 and customers.

3) 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.

4) Math Ability

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

5) Physical Demands

Sitting at a computer for long periods of time.

6) Computer Skills

Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management

7) Equipment Use

Computer and telephone

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.