QA Manufacturing Specialist II/Senior (Day Shift)

KBI Biopharma•Durham, NC

17h•Onsite

About The Position

The QA Manufacturing Specialist, Senior 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.

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

Nice To Haves

Knowledge of US and EU cGMP guidelines/regulations is desired.
Experience with electronic document management systems, SAP and Microsoft Office suite are preferred.
Knowledge of biopharmaceutical manufacturing including cell culture, protein purification, and single-use platform technology is preferred.

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.