QA Product Release

Leading Manufacturing company in Carlsbad, CA is looking to hire a QA Product Release specialist. This position is responsible for the review and release of products which have been manufactured.

ESSENTIAL DUTIES & RESPONSIBILITIES :

• Reviews and ensures that manufactured product meets its device master record requirements and is ready for product release and creates CofCs for released kits.
• Creates a nonconforming material report (NCMR) and Unplanned Deviation (UPDEV), if deficiencies are found.
• QA verification of MRB and QAHOLD on materials in ERP system
• Assist in verifying contained MRB and QAHOLD materials as needed.
• 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 MasterControl 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.
• Provide guidance to product release staff and stakeholders in the review and release 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.
• Other duties may be assigned.

POSITION REQUIREMENTS Education and Experience :

• Associate degree preferable and or Equivalent experience.
• 1-3 years of experience is preferable.
• Experience working in an FDA regulated environment and in the IVD industry is preferable.
• Experience with Master Control or similar EQMS system is a plus.
• Experience with QAD or similar ERP / systems is a plus. Skills – Technical Proficient in Microsoft Office : Especially Word and Excel for editing and tracking documents.

Google Workspace Proficiency : Skilled in using Google Docs, Sheets, and Drive for document creation, collaboration, and tracking.

Experience with Document and Change Control 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 5 : 00am - 1 : 30pm plus OT

• Experience ensuring compliance with quality standards in production batch records.
• Skills in managing documents, including indexing and archiving. Background in FDA-regulated environments, especially in the IVD industry.
• Ability to work effectively with cross-functional teams.
• Proficient in Microsoft Office (Word and Excel) and Google Workspace (Docs, Sheets, Drive) for document management.
• Familiarity with quality management systems and ISO 13485 standards.
4 days ago