Overview
The Quality Release Specialist will support review of documentation and support releasing of materials and products.
This position is shift based and onsite Wednesday through Saturday, 0800 – 1900.
Essential Functions and Responsibilities:
- Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
- Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition.
- Review of deviations as assigned.
- Revision of documents as assigned.
- Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.
- Disposition incoming materials.
- Release Tumors
- Shipment of final product
- Preparing supporting documentation for release.
- Issuance of batch related documentation.
- Support lot closure
- Other projects as assigned.
Basic Qualifications:
- A Bachelor’s Degree in Science, Engineering, or a related technical discipline with at least 2 years of experience in a regulated industry or an advanced degree without experience.
- Prior experience in cell and gene therapy preferred.
- Working knowledge of cGMP regulations.
- Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
- Attention to detail.
- Knowledge of QMS systems is a plus.
Physical Demands and Activities Required:
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Ability to lift 20 lbs.
Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline
Work Environment:
- Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
- This position will work in both an office and a manufacturing lab setting.
- When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
