What are the responsibilities and job description for the Clerk, Document Control - San Diego position at Werfen?
Overview
Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Position Summary:
The Document Control Clerk is responsible for the identification, storage, security, integrity, retrieval, retention and disposition of quality records. The Document Control Clerk ensures that documentation meets all relevant regulating agency’s standards.
Responsibilities
DUTIES/RESPONSIBILITIES:
- Maintain hard copy and electronic quality records within a GxP System
- Scan completed quality records with due diligence
- Verify the accuracy and legibility of scanned documents and upload to network folders
- Identify incomplete and/or inaccurate records
- Create inventories of quality records
- Assign the appropriate retention time for each record type
- Maintain a master inventory list
- Prepare, send and retrieve documents to and from off-site archival storage upon request
- Work with cross-functional teams to identify, file, organize and archive documents
- Ensure that records are and remain legible, readily identifiable and retrievable
- Apply Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) to daily tasks
- Work on assigned projects as needed
Qualifications
EDUCATION AND EXPERIENCE:
- High School diploma or GED.
- At least 1 year of experience in a GMP environment.
- Detail-oriented with good organization skills
- Computer literacy required; knowledge of the Microsoft Office suite
- Ability to work with minimal supervision; also be able to work as part of a team
- Good written and verbal communication skills
- Knowledge GDP and GMP desired
PERFORMANCE INDICATORS:
- Accuracy and completeness of records
- Work with minimal supervision; must also be able to work as part of a team
- Ability to use independent judgement as experience grows
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com
