Senior QA Manufacturing Specialist

KBI Biopharma • Durham, NC

3d

About The Position

The Manufacturing Quality Assurance (MQA) Senior Specialist (floor support) is responsible for assuring starting and raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. Additionally, this position is expected to identify potential problems with respect to compliance, production or testing activities and to work with the affected departments to resolve the issues. This position supports client and regulatory audits and is able to react to change productively and handle other essential tasks as assigned. The Senior Manufacturing Quality Specialist will collaborate cross-functionally with other teams to ensure product quality meets specifications and regulatory requirements.

Requirements

• Bachelor's degree in life sciences (Biology, Chemistry preferred) and >7 years’ experience or master's degree and >5 years’ experience or equivalent experience in a cGMP environment within Biopharmaceuticals (i.e., QA, technical support or manufacturing experience) is required.
• Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
• Knowledge of US, EU and cGMP guidelines is required.
• 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.

Responsibilities

• Work directly with the Manufacturing team to provide real time shop floor guidance and support.
• Provide coaching and mentoring as needed to foster a GMP compliant site.
• Perform on-the-floor review of executed records: batch, solution and equipment records and logbooks and serves as the Subject Matter Expert for executed record review.
• Support Manufacturing processing, changeover process, bulk fill Label reconciliation, facility responses, Alarm review, facility walkthroughs and other activities.
• Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level