The Senior Manufacturing Compliance Specialist supports the rapidly expanding GMP Contract Manufacturing Operation. The Senior Specialist will need to produce high quality documentation that contributes to the overall success of our operations.

Independently responsible for the efficient and thorough investigation of process deviations (that occur in manufacturing; Upstream, Downstream and/or Support),determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents. The position requires working with
minimal supervision to manage assigned investigations from initiation to completion. The Senior Specialist should have some experience in biotechnology manufacturing and quality system writing.

Represent the team in high level meetings and assume leader roles within the Manufacturing Compliance and Training Department. • In preparation for PAI readiness and in support of Audits tours, Lead and Coordinate the Manufacturing and Facilities Walkthrough Program. Identify a list of possible observations, update the Walkthrough Program Tracker and perform the corresponding follow up with area owners. • Lead, provide guidance and support to Manufacturing Compliance Specialist. • Provides training for investigative staff and aids in their professional development; explains existing policies and procedures. • Identifies issues and concerns from the investigations, leading to recommendations for review and improvement of policies, procedures, training and/or equipment. • Summarizes and explains progress and results of investigations to Management. • Lead, manage or participate in critical investigations. May represent Manufacturing Compliance and Training Management in meetings and other forums if needed. • Provide additional administrative support to Manufacturing Compliance and Training Management. As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations. • The investigator will conduct and drive closure of non-conformance events to identify root cause, product impact and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement. Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements. • Properly assess the manufacturing or analytical environment and independently conceives and documents appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using analytical tools. • Analyze existing deviations and a potential deviation focusing on establishes effective corrective and preventive actions to minimize the reoccurrence of the event. • Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience. • Complete investigations and CAPAs in alignment with established procedures and timelines. • Work across functions with a professional manner to conduct investigations and CAPAs. • Works independently to comply with procedure driven guidelines relating to Deviation investigations and CAPAs. • Demonstrates strong technical skills. Provides technical assistance to area supervisors or managers to solve complex problems. Exercises judgment in developing practices, techniques and evaluation criteria for obtaining results.

Shift: M-F 7am-7pm

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.