Industry leading organization in Carlsbad is seeking motivated individuals who are passionate about developing a career in the medical device industry.
We are actively hiring a Document Control Associate who will be responsible for the review of products :
- The production batch records are reviewed to assure compliance with the device master record and ensure good documentation practices (GDP) were followed.
- Provides clerical and administrative support related to archiving production batch records.
- Represent Quality Assurance and interact with cross-functional departments to provide quality guidance.
- Ensure compliance with all relevant quality management systems and regulatory requirements (e.g., ISO 13485, 21 CFR 820).
ESSENTIAL DUTIES & RESPONSIBILITIES :
- Reviews and ensures that the manufactured product meets its device master record requirements.
- Works with quality inspection and manufacturing personnel to facilitate efficient review.
- Responsible for handling tasks associated with Document Control, including processing, archival, filing, scanning, indexing, and formatting new and existing documents within guidance of the document control QMS procedures and the Master Control documentation software.
- Actively manages the document record retention process through the contracted documentation archival supplier.
- Assures records archived are well documented and logged to support potential future retrieval records as needed.
- Train and provide oversight to product release staff in the review of manufacturing batch records.
- Working with Document Control in archiving and retrieval of retained paper records.
- Support quality system audits by providing requested manufacturing batch records.
- Assist in verifying contained MRB and QAHOLD materials as needed.
- Other duties may be assigned.
POSITION REQUIREMENTS :
Education and Experience
- Highschool Diploma or equivalent
- 0-1 years of experience is preferable.
- Experience working in an FDA regulated environment and in the IVD industry is preferable.
- Experience with Master Control is a plus.
- Experience with ERP systems is a plus. Skills – Technical
- Proficient in Microsoft Office, especially Word and Excel, for editing and tracking documents.
- Experience with Document and Change Control electronic systems (preferably Master Control)
- Experience working with cross-functional areas (e.g., Manufacturing, Operations) Skills – General
- Must be a hands-on, self-directed, detail oriented and conscientious individual
- Complete work in a timely, accurate and thorough manner
- Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.
- Strong time management and organizational skills in a dynamic, constantly changing environment
- Ability to work effectively, exhibit a professional manner and establish constructive working relationships
1st shift : 5am - 1 : 30pm plus OT
Compensation : $19.00 - $20.00 D.O.E
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