Senior Manufacturing Compliance Specialist

Position Summary
Support cGMP manufacturing operations for manufactured biopharmaceutical products. Responsibilities include:

• Lead deviation Investigations
• Collect information, Review documentation, Conduct interviews, Perform Root Cause Analysis, Determine Product Impact, Identify CAPA(s).
• Lead Technical writing of deviations deviation reports.
• Lead CAPA implementation as applicable.
• Generate, revise, and review of standard operating procedures (SOP's) for process equipment and procedures used for production operations.
• Maintain records to comply with regulatory requirements and cGMPs.
• Interface effectively with management personnel across Manufacturing, Quality, Engineering and other technical disciplines.
• Interface effectively with clients while determining deviation root cause(s)
• Work independently, as a member of a team (including matrixed organizational structures), and work with external contractors to meet project needs and timelines.
• Staff must have in-depth knowledge and expertise in area equipment/systems, as well as independently and fully developed troubleshooting skills of equipment/processes.
• Assist with staff training, inspection preparation activities, project coordination, continuous improvement efforts to improve processes.
• May represent KBI and its programs with regulatory agencies as well as business partners.

Position Responsibilities

• Provide technical writing and investigation support for deviation reports generated at the KBI Boulder site.
• Provide review and feedback on deviation reports authored by other Technical Writer staff members.
• Support the management of quality systems programs including deviations, CAPAs, and continuous improvement.
• Support the implementation of CAPAs or authoring and review of batch documentation.

Position Requirements

• BS with 10+ years relevant experience, or MS with 7+ years
• Previous experience in a pharmaceutical manufacturing environment strongly preferred

Salary Range: $80,000-$105,000
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, 401K matching with 100% vesting in 60 days and employee recognition programs.
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.