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Position Summary:

Join a highly technical analytical team in a dynamic work environment as a member of the Analytical, Formulation and Stability (AFS) department and participate in contracted client analytical programs for monoclonal antibodies, recombinant proteins, and peptides. The AFS Compliance Specialist II will maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to good practices in quality control and data documentation and will assist AFS management in coordinating measures to increase department compliance with and awareness of regulatory requirements, as well as internal processes/systems/procedures and right-first-time initiatives.

One of the main focuses of this position is to coordinate, monitor, and track to completion the deliverables and activities associated with AFS continuous improvement projects to ensure timely completion and compliance with internal timelines, objectives, and processes/procedures. This individual will assist in the coordination of and/or participate in the development of new or revised procedures, department communications, training materials, and other deliverables associated with these projects, as able and as needed, in order to advance project completion.

The AFS Compliance Specialist II will track and monitor AFS quality records (e.g., deviations, CAPAs, change controls, laboratory investigations, etc.) for on-time closure and trends and report this information regularly to department management.

This position will provide support, as needed, for audit and inspection preparation activities, as well as ad-hoc requests from department management, including activities such as querying quality systems for requested information, summarizing queried results in presentable format, etc.

The AFS Compliance Specialist II become familiar with internal processes, systems, and procedures as needed in order to provide assistance with tasks such as development of training material for new or updated processes/systems, preparation of communications regarding new and revised procedure highlights, and other technically administrative tasks.

Position Responsibilities:

• Collaborate with department management to identify and clearly document required deliverables for continuous improvement projects and other types of special projects identified as being needed by the management team. Coordinate the assignment of deliverables to appropriate staff. Implement and/or use existing tools and processes to effectively coordinate, monitor, and track to on-time completion of the identified deliverables and activities. Obtain regular status updates from staff assigned to these deliverables, identify any roadblocks, and regularly communicate this information in a timely and effective format (e.g., meetings, presentation charts/graphs, formal email communications, etc.) to department management. Provide assistance and support to assigned staff in order to facilitate the on-time closure of these deliverables.
• Implement and/or use existing tools and processes to effectively coordinate, monitor, and track to on-time completion quality records assigned to the AFS department, including but not limited to CAPAs, deviations, laboratory investigations, change controls, periodic reviews, Calibration Alert Notifications, employee training, etc. Obtain regular status updates from staff assigned to these deliverables, identify any roadblocks and communicate this information in a timely and effective format to department management. Provide assistance and support to assigned staff in order to facilitate the closure of these records.
• Support audit and inspection preparation activities, as well as ad-hoc requests from department management as needed, including activities such as querying quality systems for requested information, summarizing queried results in presentable format, etc..
• Become familiar with internal processes/systems/procedures and provide assistance, as needed, with tasks such as development of training material for new or updated processes/systems, preparation of communications regarding new and revised procedure highlights, and other technically administrative tasks
• Able to react to change productively and handle other essential tasks as assigned. Present independency in assigned tasks.

Position Requirements:

• BS/BA and minimum 5 years of experience in CGMP regulated environment within biopharmaceuticals or equivalent, or MS/MA and minimum 3 years of experience in CGMP regulated environment within biopharmaceuticals or equivalent.
• Must have background in biopharmaceutical development, knowledge and understanding of cGMP standards and requirements, and have experience with regulatory compliance in biopharma industry.
• Proven ability to work independently and as a part of the team to resolve issues
• Strong decision making and problem-solving skills
• Demonstrated level of respect for individuals
• High level of integrity and personal responsibility
• Strong collaboration and team building skills; strong communication and interpersonal skills
• Strong orientation for quality and customer service

Salary Range: $84,000-$115,500

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.