The primary job responsibility of this position is to administrate the Fresenius-Kabi, Maricao site, Corrective and Preventive Action System in compliance with the applicable policies and procedures, the specifications, SOPs, GMPs, ISO standards and any other applicable regulatory requirements. Ensure continuous improvement of the CAPA system. Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions to control the manufacturing process
Essential Duties / Responsibilities:
1. Implement NC/CAPA Program governance and sustain.
2. Monitor and trend information related to root cause analysis, corrections, corrective and preventive actions, and tracking of timelines.
3. Recommend & execute NC/CAPA process improvement projects.
4. Ensure NC/CAPA key performance indicators compliance. Monitor other investigations related to complaint.
5. Serve as resident expert in NC/CAPA regulatory/compliance.
6. Monitor effectivity of the CAPA System.
7. Coordinate NC/CAPA weekly governance meetings and act as advisor on adequate root cause analysis, CAPA plan and effectiveness checks.
8. Assist/interface with NC/CAPA owners on investigations and action plans.
9. Conduct training on root cause analysis and problem-solving techniques.
10. Ensure compliance with specifications, SOPs, GMPs, ISO standards and any other applicable regulatory requirements.
Job Requirements:
Education:Bachelor’s degree in a Science Related field or Engineering Degree.
Experience:Seven to ten years minimum work experience in regulated industry. 5 years minimum managing CAPA Quality System. Exposition/experience managing Regulatory agencies external audits desired. Minimum 5 years of experience technical writing and/or procedure development, in medical device, pharmaceutical, or another FDA regulated environment Familiarity with requirements for regulatory submissions and guidelines for pharmaceuticals, biologics, and medical devices. Experience in reviewing and writing regulatory submission documents for global regulatory filings to include 510(k), IMPD, INDs, MAAs NDAs, and BLAs. Experience in change management.
Requirements:·
Knowledge of Pharmaceutical and Medical Device regulations, statistical sampling and analysis.
· Knowledge in laboratory, critical systems and manufacturing quality operation areas.
· Knowledge of problem-solving techniques.
· Knowledge in Process & Risk Management.
· Strong Leadership and Analytical Skills.
· Experience in managing FDA Audits.
· Knowledgeable of applicable FDA regulations and ISO Standards: 21 CFR 211/ 820 ISO 13485 and ISO 14971 and EU Medical Device Directive.
· Requires advanced critical thinking and technical writing skills
· Good organizational, communication, and interpersonal skills are necessary
· Understanding of Quality process.
· Strong knowledge of the English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
· Communicating effectively in writing as appropriate to the audience.
· Knowledge on Word, Visio, Excel, and other electronic systems to complete tasks.
Strong prioritization and multitasking skills.
Job Type: Full-time
Salary: $60,000.00 /year
Experience:
Regulated industry: 10 years (Preferred)
CAPA Quality System: 5 years (Preferred)
Education:
Bachelor's (Required)
Work Location:
Multiple locations
Benefits:
Health insurance
Dental insurance
Vision insurance
Retirement plan
Paid time off
Tuition reimbursement
This Job Is:
A job for which military experienced candidates are encouraged to apply
Schedule:
Monday to Friday
Day shift
Company's website:
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Benefit Conditions:
Only full-time employees eligible
Work Remotely:
Temporarily due to COVID-19
