Job Description
Job description
Position Summary:
The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations.
Position Responsibilities:
Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs
Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records
Support Manufacturing changeover process
Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner
Author, review, and approve deviation investigations
Support client batch record review process
Support QA Raw Material group with release of raw materials as needed
Able to react to change productively and handle other essential tasks as assigned.
Position Requirements:
QA Specialist I: Bachelor’s degree and 2 years of experience
QA Specialist II: Bachelor's degree and 6 years of experience
Experience in a cGMP QA environment or equivalent is preferred.
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-1+ vaccination, with a COVID-1+ 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, ****** 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.
Position Summary:
The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations.
Position Responsibilities:
Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs
Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records
Support Manufacturing changeover process
Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner
Author, review, and approve deviation investigations
Support client batch record review process
Support QA Raw Material group with release of raw materials as needed
Able to react to change productively and handle other essential tasks as assigned.
Position Requirements:
QA Specialist I: Bachelor’s degree and 2 years of experience
QA Specialist II: Bachelor's degree and 6 years of experience
Experience in a cGMP QA environment or equivalent is preferred.
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-1+ vaccination, with a COVID-1+ 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, ****** 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.
💡 Quick Summary
Seeking a career-building opportunity? The QA Specialist I|II |Wed|Sat| 6|00|16|30 position is now open for candidates interested in the Manufacturing Jobs sector. This role in Boulder offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Manufacturing Jobs is a plus.