What are the responsibilities and job description for the Manufacturing QA Specialist I/II position at KBI Biopharma?
Position Summary:
The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing Process and Areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site.
MQA Specialists routinely work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support. Specialists routinely collaborate with Manufacturing and work on team initiatives. The MQA Specialist may also be responsible for coaching and mentoring as needed to foster a GMP compliant site.
In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to:
- Executed Batch record review and approval
- Logbook review and approval
- Deviation guidance and generation
- Routine facility walkthroughs
- Facility response for work compromising clean environment.
- SOP review
- Bulk Fill Label reconciliation
- Alarm response and acknowledgement
- Support external client review and resolution of comments.
- Creation and Release of electronic Batch Records, electronic Solution Records, electronic Equipment Preparation Records, etc. in MODA-ES Admin Client.
Responsibilities:
- On the floor real time support of the Manufacturing process. This includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance.
- Works directly with manufacturing, and other internal departments to support resolution of client comments in a timely manner in support of batch release activities.
- Works directly with manufacturing, the laboratory, and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner.
- Facility Walkthroughs.
- Quality representation on interdepartmental meetings.
- Support process improvement projects to include improving on the floor Quality activities, record review time, and batch release dates.
- Able to react to change productively and handle other essential tasks assigned.
- Other duties consistent with knowledge, skills and ability as assigned.
Requirements:
MQA Specialist I
- High School diploma or equivalent. Degree progression preferred
- GMP / regulated industry / laboratory experience is required (approximate 1-3 years).
- Demonstrated ability to work in a team environment.
- Demonstrated ability to understand the manufacturing process.
- Ability to perform routine core MQA responsibilities.
- Review written procedures for accuracy and provide feedback as needed
MQA Specialist II
- Associate degree / Bachelor’s degree strongly preferred or appropriate years of experience (approximate 3-6 years).
- Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
- Demonstrated ability to represent Quality on interdepartmental meetings.
- Demonstrated knowledge of technical documents.
- Demonstrated ability to become qualified trainers.
- Ability to track and trend department metrics.
- Review written procedures for accuracy and provide feedback as needed
Salary Range: MQA Specialist I: $55,000 - $75,900 ; MQA Specialist II: $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 : $55,000 - $75,900
