QA Analyst

About Us:

For 75 years, Fujirebio Diagnostics Inc., is a leading worldwide biotechnology Company and the innovation engine behind diagnostic breakthroughs that reach patients worldwide. Our in vitro diagnostics (IVD) technology powers critical tests across the globe's leading diagnostic platforms. We are a biomarker and diagnostic content provider that strengthens diagnostics for everyone. Through our approach of innovation, clinical evidence and global CDMO partnerships, we ensure that next-generation biomarkers are accessible across diagnostic platforms, so patients benefit no matter which system is used.

Position Summary:

The QA Analyst prepares and reviews the necessary documentation used in the manufacturing and release of final product. Based on the review of this documentation, makes recommendations to release or reject the final product. Assures overall compliance with internal specifications, external specifications and FDA regulations. Responsible for maintaining lot history files, auditing the manufacturing processes and assuring that documents are issued by the manufacturing personnel according to the appropriate SOPs.

Essential Job Functions:

Audits complete batch records for correctness and completeness of documents according to appropriate SOPs. Determines release/reject disposition of products and components. Completes all required in-process and final release documentation. Participates in QA improvement and training projects. Logs all completed documents back into the Quality Data Interchange System (QDI). Assists in system maintenance by entering new item numbers, training and process flows. Issues labeling and packaging documents through QDI or POMs. Changes status in QDI to reflect disposition of materials (release/reject MRB, etc.). Prepares protocols and certificates and ensures correct protocols are scanned and sent to distributors. Serves as primary contact for assigned partnered product lines and assigned partner functions. Maintains file system, history files and archived documents. Assures completed documents are filed correctly. Handles requests for archived documentation. Participates in new product implementation, as required. Assures adherence to SOPs with monitoring and revision or creation of protocols and procedures as necessary to assure accuracy and compliance to Master Device Records. Assures that all operations are performed according to SOPs and procedures and that any deviations from procedures are reported immediately to QA management and the responsible departments. Identifies quality problems to QA management and recommends solutions. Actively participates in resolution of documentation and compliance issues. Provides support for quality investigations, as needed. Contributes to Continuous Improvement QA idea board. Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner. Performs other duties as assigned. Job Specifications (skills, knowledge, special training, certification, license requirements): Knowledge of cGMPs, QA, QC and manufacturing/quality processes Must be detail-oriented Ability to work on a keyboard and aptitude for word processing, spreadsheets and databases Strong math aptitude Ability to accurately document, transcribe and verify numbers and words Must have excellent communication skills and the ability to work with various levels of staff Must be able to work in a deadline-oriented, face-paced environment Excellent attendance and ability to work overtime required

Education and Work Experience Required:

Bachelor's degree (life science/medical technology preferable) or equivalent work experience required. Minimum of 2 years of experience in a GMP-related industry The base salary range for this position is $57,000- $62,000/year. The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. The typical work schedule for this position is a 4-day work week, Monday to Thursday. We offer a competitive benefits package that starts on day one, including three medical plans, savings and spending accounts, employer-paid dental & vision, 401(k) match up to 6%, life insurance and disability, educational assistance, EAP, generous Paid Time-Off, paid holidays, and opportunity for advancement. We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted. Fujirebio Diagnostics is an Equal Employment Opportunity Employer