What are the responsibilities and job description for the QA Specialist I/II (Shop Floor) (Days) 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 internal customers 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 in order to provide real time guidance and support. Specialists routinely collaborate with internal customers 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 internal customers, MQA Specialists are responsible for the execution of core activities, including but not limited to:
MQA Specialists routinely work on the cleanroom floor directly with the Manufacturing team in order to provide real time guidance and support. Specialists routinely collaborate with internal customers 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 internal customers, MQA Specialists are responsible for the execution of core activities, including but not limited to:
- Executed record review and approval (BRs, SRs)
- Logbook review and approval
- Deviation guidance and generation
- Routine facility walk throughs
- Facility response for work compromising clean environments
- SOP review and approval
- Bulk Fill Label reconciliation
- Alarm response and acknowledgement
- Review of Manufacturing Batch Records, including internal, client and master batch records
- Support conditional and final release activities for disposition of bulk drug product
- Support external client review and resolution of comments
Position 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 (to include logbooks as needed)) , 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. Communicates directly with clients to resolve issues related to batch disposition.
- 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.
- Supports training and mentoring of other Quality department staff to perform quality duties as needed.
- Technical Writing / Review /Approval (SOPs, Process Documents, FMEAs, Criticality Assessments, etc.)
- 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
Position Requirements
MQA Specialist I
- High School diploma or equivalent. Degree progression preferred. GMP experience is preferred. Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities
MQA Specialist II
- Associates Degree / Bachelor’s Degree strongly preferred or appropriate years experience. 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. Ability to provide MQA assessments for Change Controls, Deviations/CAPAs, Criticality Assessments with limited oversight.
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.
