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

Socket.dev; Boulder (CO); On-site; USD 67,000 - 85,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards, internal procedures, and government regulations in support of cGMP operations.

The role includes reviewing records, authoring SOPs and batch records, supporting changeovers, resolving deviations with GMP teams, and assisting with raw material releases and client batch reviews; night shift differential applies.

Qualifications

• Bachelor's degree and 2 years of experience for QA Specialist I.
• Bachelor's degree and 6 years of experience for QA Specialist II.
• Experience in a cGMP QA environment or equivalent is preferred.

Responsibilities

• Perform compliance review on batch and solution records and associated forms, data, and logs
• Author new and revised SOPs, forms/logs, Master Batch Records and Solution Records
• Support Manufacturing changeover process
• Collaborate with GMP teams to resolve deviations in a timely manner
• Author, review, and approve deviation investigations
• Support QA Raw Material release and client batch record review as needed
• Be adaptable to change and perform other essential tasks

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.