QA Release Technician
Job brief
Job Task(s)
- 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 regulations
- General calculations of units of measure, using whole numbers, common fractions, percentages and decimals during documentation verification.
Requirements
General Requirements
This position will require the employee to fulfill the following general requirements for employment at Stallergenes Greer and includes but is not limited to:
- Practice good hygiene and personal sanitation practices
- Compliance with applicable standard operating procedures
- Compliance with company environmental health and safety procedures
- Protect and preserve Stallergenes Greer physical property and equipment
- Protect and preserve Stallergenes Greer intellectual property and confidential information
Education Requirements
This position requires the following minimum education:
- Associates or bachelor’s in science field
Work Experience Requirements
- Prior Pharmaceutical manufacturing experience helpful but not required.
Computer Skill(s)
- General internet use
- General use of Microsoft® Word and Excel
About STALLERGENES GREER International AG
Stallergenes Greer is an international biopharmaceutical company specialized in the diagnosis and treatment of allergies through the development and marketing of Allergenic Immunotherapy treatments.
Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.
Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.
With nearly 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 41 countries.
Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment ? Join our Stallergenes Greer teams !
- Job category : Quality Assurance
- Job type : Full time
- Contract type : Permanent contract (CDI)
- Job location : United States
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