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Quality Assurance Analyst
Job LocationUS-PA-Jessup
Type
Full-TimeCategory
QualityShift
Non-Shift (Standard Business Hours 8:15am-4:30pm EST)Job ID
2024-6886Min
USD $51,772.00/Yr.Overview/RisksEnsure that the documentation review performed for the release of tissue and medical devices is according to current MTF procedures and in compliance with applicable regulatory requirements.
M-F, 8:15am to 4:30pmResponsibilitiesReview release criteria in accordance with current finished good (FG) specifications, in-process finished goods (IFG) specifications, MTF procedures for tissue and medical devices, and applicable regulatory requirements.
Identify deviations, discrepancies, or non-conformances associated with the work order. Notify the appropriate individuals, complete the necessary documentation, and ensure the deviations, discrepancies, or non-conformances have been resolved before the tissue or medical device units are released.
Responsible for initiation, containment, and completing other action items assigned of non-conformances.
Review non-conformances, problem statements, investigations, root cause analysis and risk assessments, and other applicable action items for closure of non-conformances.
Print testing result reports from outside laboratories and internal MTF laboratories for review and incorporation into the processing record, if applicable.
Complete appropriate documentation for the rejection of tissue and medical devices when required.
Review recorded measurements for tissue and medical devices in accordance with current FG specifications and MTF procedures.
Review packaging and labeling documentation for tissue and medical devices in accordance with current FG specifications, MTF procedures, and applicable regulatory requirements.
Review tissue and medical device processing and storage documentation in accordance with current MTF procedures and applicable regulatory requirements.
Interact with all departments to organize, review, and analyze all data pertaining to the release of tissue or medical devices for compliance with current MTF Procedures, IFG and FG specifications, and applicable regulatory requirements.
Release tissue and medical devices to Inventory Control for international and domestic distribution.
Review rework work orders and ensure the accurate destruction of tissue, if required.
Enter all required data into the Quality Donor Data System (QDDS) and perform appropriate actions in QAD following review of tissue or medical devices.
Perform additional duties, as assigned.QualificationsAssociate's Degree or equivalent combination of education and/or work experience
1 year Experience in a GMP or FDA regulated industry.
3 years Document review or laboratory testing
Strong written and verbal communication skills
Must be proficient in data entry, Microsoft Outlook, Word, and Excel
Must exhibit attention to detail, critical thinking, problem-solving and effective communication.Need help finding the right job?We can recommend jobs specifically for you!
Click here to get started.Equal Opportunity Employer - Vet/Disability
Vacancy caducado!