QA Manufacturing Specialist II/Senior (night shift)

Please Note: This is a night shift opportunity that follows a 2-2-3 schedule. It will be eligible for a shift differential.

Job Summary

The QA Manufacturing Specialist is responsible for ensuring raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations.

This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for on the floor review of executed records (batch record section review, solution records, equipment records, and logbooks) supporting all aspects of cGMP operations. Client and regulatory audit/inspection support is also within job scope.

Job Responsibilities

• Perform on-the-floor compliance review on executed records including batch records, equipment preparation records, and solution record and associated forms, in-process data, and logbooks.

• Perform activities such as manufacturing walk-throughs, facility responses, label reconciliation, etc.

• Support Manufacturing changeover process.

• Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations, CAPAs, and other compliance issues in a timely manner

• Support client audits and regulatory inspections and client batch record review process.

• Support QA Raw Material group with release of raw materials

• Able to react to change productively and handle other essential tasks as assigned.

• Review document revisions (SOPs, Forms, Solution Records, etc)

• Supports training of other Quality department staff to perform quality duties as needed.

• Support process improvement projects to include improving the lifecycle of batch record review cycle times and batch release dates.

Minimum Requirements

• MQA Specialist II: BS/BA in scientific field and 5 years experience or MS/MA degree and 3 years’ experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent is required.

• MQA Senior Specialist: BS/BA degree in scientific field and 8 years experience or MS/MA degree and 6 years’ experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent is required.

• Knowledge of US and EU cGMP guidelines/regulations is desired.

• Experience with electronic document management systems, SAP and Microsoft Office suite are preferred.

• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.

• Knowledge of biopharmaceutical manufacturing including cell culture, protein purification, and single-use platform technology is preferred.

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.