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.

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. The role 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 the job scope.

• 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, 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.
• React to change productively and handle other essential tasks as assigned.
• Review document revisions (SOPs, forms, solution records, etc).
• Support training of other quality department staff to perform quality duties as needed.
• Support process improvement projects to improve the lifecycle of batch record review cycle times and batch release dates.

• MQA Specialist II: BS/BA in a 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 a 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 is preferred.
• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem‑resolution 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 workforce. 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.