QA RELEASE TECHNICIAN

Description

Stallergenes Greer is a fully integrated global biopharmaceutical company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergen immunotherapy (AIT) products and services.

QA Product Release Technician Hours:

• 8AM-5PM Monday-Friday, onsite 

QA Product Release Technician Education Requirements:

• Bachelor's degree in a scientific field preferred.

QA Product Release Technician Primary Responsibilities:

This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:

• Ensure that all SOPs and master batch records, paper or electronic, follow cGMP requirementas and are in accord with business needs.
• Manage the release of commercial lots, review batch records after execution. Participate in the lot disposition decisions and complete lot disposition. Identify issues and support correction process.
• Support audits and inspections by ensuring all documents are readily available and organized.
• Verify that all products have met all testing requirements and manufacturing specifications prior to releasing the batch records. Identify issues and support correction process.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Provides support for submissions to CBER for release by completing and reviewing the required documentation. Review documentation meets good documentation procedures and calculations are correct.
• Manages and/or assists in the disposal of discarded product discovered during inspection process according to procedure.
• Collation and organization of batch records for submission to DCO.
• Seek continuous improvement opportunities to enhance quality systems
• Enters work order completion information into JD Edwards computer applications and enters recorded values in electronic systems.
• Manage KPIs for Quality Assurance Release.
• Assist in developing and implementing an electronic batch record system.
• Good working knowledge of current regulations including FDA, ICH, USP guidance.

EOE, including disability/vets

Requirements

Physical Demand(s)

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to routinely lift approx. 50 lbs.
•      While performing the duties of this job, the employee is frequently required to sit and talk or hear.
• Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

 

Computer Skill(s)

• General internet use
• General use of Microsoft® Word and Excel

Education:

Associates or Bachelors in Science field

Summary

Stallergenes Greer is a fully integrated global biopharmaceutical company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergen immunotherapy (AIT) products and services.

Our purpose is to enable precision medicine to improve life for people with allergies.

Stallergenes Greer has an extensive global footprint, the largest allergen and finished AIT product manufacturing capacity globally. The company’s broad product portfolio, available in multiple formulations (subcutaneous, sublingual drops and tablets), offers patients innovative solutions to improve life for people with allergies.

Develops allergen immunotherapy treatments for diagnosing and treating allergies.