Quality Applications Specialist
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Summary:
- Conducts a compliant validation process for quality information technology systems requiring formal validation documentation (including standard operating procedures) under applicable federal regulations.
- Coordinates activities with clients programmers/developers and operating personnel both domestically and as appropriate globally.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification implementation and maintenance of procedures actions and documentation necessary to assure compliance with federal and international regulations governing user applications.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Keeps abreast of changing federal and international regulatory requirements government audit policies and new validation techniques.
- Performs system administration and configuration of quality information technology systems.
- Supports day-to-day manufacturing activities leads and participates in investigations and drives improvement projects within the manufacturing environment.
*Other duties may be assigned.*
Minimum Requirements:
- Bachelors degree in Science or Engineering.
- Minimum of 2 years of relevant experience.
- 23 years experience with Sterilization Validation / Microbiology (desirable).
- Experience in manufacturing environments.
- Experience with Process Validation.
- Ability to understand and follow change control processes.
Preferred Qualifications (Nice to Have):
- Investigation and root cause analysis skills.
- CAPA (Corrective and Preventive Actions) knowledge or experience.
Work Methodology:
- Full time contract
- 100% on-site job in Medtronic- Villalba PR
- Administrative Shift
- 2 yearsof first contractbasedto performance and budget availability.
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
