QA Product Release I

Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities.Eastridge is seeking a QA Product Release I for a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost of care. 1st shift; 5 am-1:30 pm plus OTResponsibilities: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 recordsWorking 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.Requirements: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 - GeneralMust be a hands-on, self-directed, detail oriented and conscientious individualComplete work in a timely, accurate and thorough mannerProven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment.Strong time management and organizational skills in a dynamic, constantly changing environmentAbility to work effectively, exhibit a professional manner and establish constructive working relationships_Benefits: Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge's temporary employees.From time to time Eastridge's clients may offer additional benefits to Eastridge employees while on assignment.Information about those benefits will be communicated when applicable.Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.#IPRO