QA Specialist Senior, QA Manufacturing (Day Shift)

JOB SUMMARY:

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.

JOB 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.

MINIMUM 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.

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.