Product Release Specialist II
About The Position
Responsible for release of batch records from Quality Operations through review of electronic and/or manual device history to ensure quality standards are met. The product release specialist will follow prescribed steps to document issues and follow-up on corrective actions, as needed. Documents batch release process and mentors less experienced staff on implementation. Reviews batch files to ensure storage and maintenance is in accordance with business policies. Makes recommendations and provides support to corrective actions. Administers requests for rework and destruction of materials. Adheres to environmental policy and procedures and supports department environmental objectives.
Requirements
- High School Degree or equivalent.
- 1-3+ years experience in a Quality Assurance/Regulatory Affairs environment (e.g. performing audits, reviewing large volumes of data in a short period of time, etc)
- Strong attention to detail and critical thinking skills
- Ability to work in a self-directed dynamic environment.
- Perform under pressure in a fast paced environment.
- Flexible work schedule to included overtime on short notice.
Nice To Haves
- Knowledge of Quality System Regulations (GMPs), preferred
- Knowledge of validated JJV systems (eDHR, MES, VIBES), preferred
Responsibilities
- Reviews electronic and manual records pertinent to device history and sterilization.
- Investigates and resolves discrepancies.
- Participates in training and development of Product Release staff.
- Responsible for manual DHR documents to be filed for storage per procedure.
- Participates in the development and implementation of new systems directly and indirectly impacting Product Release.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
