QA Release Technician

Job 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.

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.

Primary Responsibilities

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

Verifies that all products have met all testing requirements and manufacturing specifications prior to release.

Assures that all autoclave loads were performed according to SOP (Standard Operating Procedures).

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 the required documentation. Assures that the department’s Standard Operating Procedures are current and in compliance.

Manages and/or assists in the disposal of discarded product discovered during inspection process according to procedure.

Enters work order completion information into JD Edwards computer applications and enters recorded values for lots including manufacturing dates, PNU values, Antigen E, etc. from test results.

Completes the annual Retention Vial inspection for Extract Bulks.

General understanding of applicable governmental regulation, general calculations of units of measure, using whole numbers, common fractions, percentages and decimals during documentation verification.

QA oversight for extract inspection and labeling production.

Collation records for submission to DCO

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