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Our client is a biologics company, looking to hire a?QA Analyst/Documentation Associate?on a 3-6 month basis to cover a leave of absence.
Salary/Hourly Rate:?Up to $23 per hour DOE
Position Overview:?The?QA Analyst/Documentation Associate will ensure that the documentation review performed for the release of tissue and medical devices is according to current company procedures and in compliance with applicable regulatory requirements. Office environment.
Responsibilities of the?QA Analyst/Documentation Associate: Reviews release criteria in accordance with current finished good (FG) specifications, in-process finished goods (IFG) specifications, Company procedures for tissue and medical devices, and applicable regulatory requirements Identifies deviations, discrepancies, or non-conformances associated with the work order
Notifies the appropriate individuals, completes the necessary documentation, and ensures the deviations, discrepancies, or non-conformances have been resolved before the tissue or medical device units are released Completes appropriate documentation for the rejection of tissue and medical devices when required Reviews prints testing result reports from outside laboratories and internal MTF laboratories for review and incorporation into the processing record, if applicable Reviews recorded measurements for tissue and medical devices in accordance with current FG specifications and Company procedures Reviews packaging and labeling documentation for tissue and medical devices in accordance with current FG specifications, company procedures, and applicable regulatory requirements Reviews tissue and medical device processing and storage documentation in accordance with current MTF procedures and applicable regulatory requirements Interacts with all departments to organize, review, and analyze all data pertaining to the release of tissue or medical devices for compliance with current Company procedures, IFG and FG specifications, and applicable regulatory requirements Releases tissue and medical devices to Inventory Control for international and domestic distribution Reviews rework work orders and ensure the accurate destruction of tissue, if required Enters all required data into the Quality Donor Data System (QDDS) and transfers Work-In-Process (WIP) tissue to the appropriate location Qualifications for the?QA Analyst/Documentation Associate: MUST have pharmaceutical, biopharmaceutical, or biologics industry experience MUST have at least 2 years of experience working with NCRs (non-conformance reports), performing batch record review, QA documentation review, or handling customer complaints MUST have at least 2 years of experience working in a GMP or FDA environment Strong written and verbal communication skills. Must be proficient in data entry, Microsoft Outlook, Word, and Excel. Must exhibit attention to detail, critical thinking, and problem-solving and effective communication skills Education Requirements:? High School Diploma Benefits:?Eligible for Atrium Care Package
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Associated topics: automation, process, prevent, prevention, quality assurance, quality assurance engineer, software quality, software quality engineer, test engineer, tester

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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