QA Release Technician

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-5

PM Monday-Friday 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

Job Type:

Full-time Pay:

From $20.00 per hour

Benefits:

401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): What are your salary expectations for this role?

Education:

Bachelor's (Preferred) Ability to

Commute:

Lenoir, NC 28645 (Required)

Work Location:

In person