Product Release Manager
Job brief
Specific Job Requirements
This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:
Job Task(s)
- Ensure all laboratory testing is within release criteria for product release
- Evaluate and trend all QC data
- Approve investigations for deviations, OOS, OOL, and QCM deviations for appropriate disposition of product
- Review and disposition final product for release based on manufacturing and batch release specifications
- Lead quality improvement for QA release personnel
- Train and develop leaders in QA investigations
- Develop standard work and decision trees for investigations and release activities
- Implement a career ladder for QA release personnel
- Coordinate with QC managers and supervisors to develop and implement an industry leading QC program
- Coordinate with Strategic Quality Manager to implement quality release and investigations quality improvements
- Responsible for authoring the Annual Product Quality Review (APQR) for Stallergenes Greer (Lenoir site)
Requirements
Education Requirements:
This position requires the following minimum education:
- B.S in a scientific discipline
Work Experience Requirements:
- 5 years of experience in a cGMP Manufacturing Environment
- Strong computer skills, preferable experience with Inventory software and/or Manufacturing software
- Working knowledge of electronic quality management systems
- Hands on experience within the laboratory and/or manufacturing
Direct experience leading teams and / or functional areas
Physical Demand(s)
- The employee must occasionally lift and/or move up to 10 pounds.
Computer Skill(s)
- Microsoft Office (i.e. Word, Excel, Access)
- Inventory software and/or Manufacturing software
- Electronic Quality Management Systems
Additional Skills
- Working knowledge of pharmaceutical cGMPs’s-21 CFR Part 210 and 211, 21 CFR 820
- Excellent technical writing skills
About STALLERGENES GREER International AG
Stallergenes Greer is an international biopharmaceutical company specialized in the research, diagnosis and treatment of respiratory, food and venom 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 more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 44 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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