What are the responsibilities and job description for the Facilities Compliance Specialist position at KBI Biopharma?
Summary:
The Facilities Compliance Specialist supports the Facilities Engineering Department as a part of a rapidly expanding GMP Contract Manufacturing Operation. The Specialist will need to produce high-quality documentation that contributes to the overall success of our operations. The Specialist will be responsible for the completion of Facilities Engineering Change Controls, CAPAs, Deviations, Risk Assessments, SOPs, and other quality documentation. The candidate will exercise good communicative and collaborative skills to work with department SMEs and the site Quality and Regulatory organizations. The candidate will ensure that department compliance measures are maintained, all documentation meets regulatory requirements, and is completed according the determined target timelines. The candidate should have experience in biotechnology manufacturing and quality system writing. The candidate may also lead or act as a team member for special projects as determined by the Department Head in support of continued improvement of department goals and initiatives.
Responsibilities:
years of pharmaceutical or related work experience with emphasis on current
Good Manufacturing Practices including: QA, QC, Validation, Manufacturing,
Maintenance, or Engineering.
Preferred:
Ability to write routine reports and correspondence. Ability to speak effectively
before internal groups or employees of organization. Good deductive and
Inductive Critical Thinking Skills Required.
Reasoning Ability
Math Ability
percent and to draw and interpret bar graphs.
Salary Range: $63,000 - $86,900
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.
The Facilities Compliance Specialist supports the Facilities Engineering Department as a part of a rapidly expanding GMP Contract Manufacturing Operation. The Specialist will need to produce high-quality documentation that contributes to the overall success of our operations. The Specialist will be responsible for the completion of Facilities Engineering Change Controls, CAPAs, Deviations, Risk Assessments, SOPs, and other quality documentation. The candidate will exercise good communicative and collaborative skills to work with department SMEs and the site Quality and Regulatory organizations. The candidate will ensure that department compliance measures are maintained, all documentation meets regulatory requirements, and is completed according the determined target timelines. The candidate should have experience in biotechnology manufacturing and quality system writing. The candidate may also lead or act as a team member for special projects as determined by the Department Head in support of continued improvement of department goals and initiatives.
Responsibilities:
- Support CAPAs, Change Control, Deviation, Risk Analysis, Root Cause Analysis and other Quality Systems.
- Support Engineering, Validation, Maintenance, and Metrology in the develop and revision of Standard Operating Procedures (SOPs), completion of periodic reviews, and other quality documentation.
- 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.
- Assist in generation of department quality metrics and track the status of active records.
- Complete special projects and other assigned duties to achieve department goals.
- BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry,
years of pharmaceutical or related work experience with emphasis on current
Good Manufacturing Practices including: QA, QC, Validation, Manufacturing,
Maintenance, or Engineering.
Preferred:
- Knowledge of the facilities operation typical to the biotechnology/pharmaceutical
- Worked closely with Engineering, Validation, or Maintenance.
- Ability to read and interpret English documents such as safety rules, operating
Ability to write routine reports and correspondence. Ability to speak effectively
before internal groups or employees of organization. Good deductive and
Inductive Critical Thinking Skills Required.
Reasoning Ability
- 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. Strong time management skills and an ability to multitask in a face paced environment. Ability to deliver high quality documentation paying attention to detail.
- Ability to quickly grasp complex technical concepts and make them easily
Math Ability
- Ability to add, subtract, multiply, and divide in all units of measure, using whole
percent and to draw and interpret bar graphs.
Salary Range: $63,000 - $86,900
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.
Salary : $63,000 - $86,900
