What are the responsibilities and job description for the Product Release Manager position at Stallergenes Greer?
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)
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
Job Type: Full-time
Pay: Up to $115,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
Schedule:
- Monday to Friday
Education:
- Bachelor's (Required)
Ability to Commute:
- Lenoir, NC 28645 (Required)
Ability to Relocate:
- Lenoir, NC 28645: Relocate before starting work (Required)
Work Location: In person
Salary : $115,000
