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CAPA Process Analyst

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GTT, LLC

2024-10-02 21:41:01

Job location San Diego, California, United States

Job type: fulltime

Job industry: Administration

Job description

Job Title: CAPA Process Analyst (Quality Assurance)

Duration: 12 months contract

Pay Range: $35.97/hr

Location: San Diego, CA

Work Type: Onsite

About the Role

As a CAPA Process Analyst, you will play a critical role in ensuring the effective management of our CAPA system within our IDDM business unit. You will work closely with cross-functional teams to maintain compliance with internal and external quality standards.

Responsibilities

CAPA Administration: Oversee the CAPA system, ensuring its efficient operation and adherence to regulations.

Process Support: Provide guidance to process owners in completing CAPAs and related tasks.

Corrective Action Review Board Support: Assist the board and users in understanding the CAPA process, record content, and software.

Quality System Improvement: Contribute to the development, implementation, and continuous improvement of CAPA procedures, software, and training.

CAPA Implementation: Ensure effective implementation and verification of CAPA processes, including remediation of legacy files.

Record Management: Maintain accurate and complete CAPA records, linking them to other relevant quality processes.

Document Review: Conduct critical reviews of documents, assessing evidence and ensuring compliance.

Quality Management Support: Provide ongoing support during external audits and ensure adherence to quality standards.

Professional Conduct: Exhibit professional behavior, build positive relationships, and comply with company policies.

Qualifications

Required:

Bachelor's degree or equivalent experience in an FDA-controlled environment.

Preferred:

Bachelor's degree in a technical field (e.g., engineering, science).

1-2 years of experience in a compliance-focused professional environment.

Knowledge of QSR or ISO 13485.

Experience in quality assurance within a medical device manufacturing environment, preferably in-vitro diagnostics.

Proficiency in MS Office.

Strong organizational skills and attention to detail.

Excellent written and verbal communication skills.

Effective interpersonal skills and the ability to collaborate with cross-functional teams.

Strong analytical and problem-solving skills.

Benefits:

Medical, Vision, and Dental Insurance Plans

401k Retirement Fund

About The Company:

Global Healthcare Innovator

We're a leading healthcare company dedicated to improving lives worldwide. Our diverse portfolio includes medical devices, diagnostics, nutrition products, and branded generics. We're committed to developing groundbreaking technologies that address critical healthcare challenges and empower people to live healthier lives.

Join our team and:

Work on cutting-edge projects

Contribute to global healthcare advancements

Experience diverse cultures and geographies

Client a rewarding career with a company that cares.



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