KBI BioPharma
Manufacturing Compliance Specialist I/II (Nights)
KBI BioPharma, Durham, NC, United States
Please Note: This position is a night shift position that operates on a 2-2-3 schedule and is eligible for a shift differential.
JOB SUMMARY:
The incumbent will support GMP downstream manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department. The individual will support downstream operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed.
The individual will support downstream operations during the execution stage by tracking manufacturing records and logbooks in execution. They will also support ERP system reconciliation, manufacturing record and logbook reviews and track them through their post execution life cycle.
The individual will monitor GDP execution and provide feedback, coaching, and training to ensure 'Right the First time' execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle.
The individual will ensure the downstream manufacturing training plan is set appropriately and track training metrics and compliance for the department. They will also provide training for CAPAs and production issues as needed.
The individual will oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls. They will initiate and complete deviations, capas, and change controls, as needed, to support operations. They will also support facility changeover activities and coordinate equipment maintenance as needed.
Lastly, the individual will author, train, and review manufacturing procedures as needed and perform additional duties as assigned.
JOB RESPONSIBILITIES
SALARY RANGE
Manufacturing Compliance Specialist I: $52,493 - $72,177.60
Manufacturing Compliance Specialist II, it's $61,090 - $83,998.20
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.
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.
JOB SUMMARY:
The incumbent will support GMP downstream manufacturing operations for late-phase and commercial mammalian Cell Culture programs and oversee compliance activities for the department. The individual will support downstream operations during the planning stages by releasing electronic manufacturing logbooks and records, as needed.
The individual will support downstream operations during the execution stage by tracking manufacturing records and logbooks in execution. They will also support ERP system reconciliation, manufacturing record and logbook reviews and track them through their post execution life cycle.
The individual will monitor GDP execution and provide feedback, coaching, and training to ensure 'Right the First time' execution of manufacturing documentation. They will also track metrics for executed manufacturing records and logbooks throughout their entire lifecycle.
The individual will ensure the downstream manufacturing training plan is set appropriately and track training metrics and compliance for the department. They will also provide training for CAPAs and production issues as needed.
The individual will oversee the departmental compliance activities and metrics as it pertains to deviations, capas, and change controls. They will initiate and complete deviations, capas, and change controls, as needed, to support operations. They will also support facility changeover activities and coordinate equipment maintenance as needed.
Lastly, the individual will author, train, and review manufacturing procedures as needed and perform additional duties as assigned.
JOB RESPONSIBILITIES
- Release electronic manufacturing records and logbooks.
- Perform reviews of electronic logbooks and manufacturing records.
- Prepare and track departmental manufacturing records and logbooks throughout entire lifecycle and support executed record reviews and comment resolution
- Author, train, review manufacturing procedures
- Oversee and execute against departmental compliance activities associated with QA Systems such as deviations, CAPAs, and change controls.
- Develop and oversee manufacturing training plan, and training compliance for department.
- Experience in production or quality assurance of GMP manufacturing is required.
- Experience working with electronic quality management systems such as documentation, deviations, capas, and change control systems is preferred.
- Experience working with electronic manufacturing records or logbooks is preferred.
- Experience working in biopharmaceutical manufacturing is preferred.
- Excellent written and verbal communication skills are required.
- Strong attention to detail, as well as, presentation, written, and verbal communication skills required.
- Energetic, motivated and dynamic individual.
- Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
- Specialist I B.A./B.S. in a Life Sciences or Engineering degree and 2+ years relevant experience or HS Diploma and 6+ years of experience.
- Specialist II B.A./B.S. in a Life Sciences or Engineering degree and 4+ years relevant experience or HS Diploma and 10+ years of experience.
SALARY RANGE
Manufacturing Compliance Specialist I: $52,493 - $72,177.60
Manufacturing Compliance Specialist II, it's $61,090 - $83,998.20
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.
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.