QA Manufacturing Specialist I/II (4x10, 1900 - 0530)

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 67,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards, internal procedures, and regulatory requirements.

This role provides broad QA oversight for bulk drug substance manufacturing and reviews executed procedures, equipment logs, and batch records. The position involves authoring SOPs, supporting changeovers, resolving deviations, and collaborating across manufacturing, R&D, and QA

Qualifications

• Bachelor's degree and 2 years of QA experience for Specialist I or 6 years for Specialist II.
• Experience in a cGMP QA environment preferred.
• Familiarity with SOPs, batch records, and change control processes.

Responsibilities

• Perform compliance review on executed records: batch and solution records and relevant logs.
• Author new and revised SOPs, forms/logs, Master Batch Records and Solution Records.
• Support Manufacturing changeover processes.
• Collaborate with Manufacturing, Laboratory and other GMP teams to resolve deviations.
• Author, review, and approve deviation investigations.
• Support QA Raw Material release activities as needed.
• Adapt to changing product needs and perform other essential tasks.

Skills

Quality Assurance

GxP / cGMP

Documentation review

Education

Bachelor's degree

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

Salary: $67,000 - $85,000

This is a night shift position and will be eligible for a shift differential in addition to base salary.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.