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

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

Job summary

KBI Biopharma is seeking a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards and government regulations. This role provides broad QA oversight for activities supporting bulk drug substance manufacturing.

Responsibilities include review and approval of batch records, SOPs, deviation investigations, and collaboration with GMP teams to resolve deviations promptly. Night shift with shift differential.

Qualifications

• Bachelor’s degree required with 2 years of experience for QA Specialist I
• Bachelor’s degree with 6 years of experience for QA Specialist II
• Experience in a cGMP QA environment or equivalent preferred

Responsibilities

• Perform compliance review on batch and solution records, on-the-floor data, and logs
• Author or revise Standard Operating Procedures (SOPs), forms/logs, and batch/solution records
• Support manufacturing changeovers and resolve deviations with GMP teams
• Review, approve deviation investigations and batch records for QA release
• Assist QA Raw Material team with raw material release as needed

Skills

Quality assurance

GMP compliance

Documentation review

Deviation investigations

SOP writing

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 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.