Quality Assurance Analyst I - Production Quality Assurance

Company Overview

Menarini Silicon Biosystems, Inc. develops technologies and products that help scientists and clinicians better understand the biological complexity of disease through the study of rare single cells. Utilizing rare cell analysis, the company is focused on fulfilling the vision of precision personalized medicine — disease diagnosis, prevention and treatment that considers each person’s genetic variability. Menarini Group is multinational pharmaceutical, biotechnology and diagnostics company based in Florence, Italy with a heritage in healthcare spanning 130 years and over 17,000 employees in more than 100 countries. Menarini Silicon Biosystems is a wholly-owned subsidiary of The Menarini Group, with European headquarters in Bologna, Italy and U.S. headquarters in Huntingdon Valley, PA.  Silicon Biosystems produces and distributes multiple discovery and diagnostic platforms, as well as operates a CLIA-certified clinical laboratory. 

The Company’s DEPArray™ System is the only automated instrument that can identify, quantify, and recover individual rare cells. Its DEPArray™ technology enables isolation of individual, intact cells, to study the biological significance of rare cells in disease development, progression, and therapeutic response. The DEPArray™ System can analyze samples containing from one to tens of thousands of cells and is compatible with a wide variety of rare cell suspensions, including live and fixed cells; enriched cells; and samples with small cell loads, such as fine needle aspirates and tissue biopsies. Applications include oncology research, forensics, fetal and stem cell biology, drug response, and downstream genomic analysis.

Menarini Silicon Biosystems’ CELLSEARCH® Circulating Tumor Cell System the first and only clinically validated blood test cleared by the U.S. Food and Drug Administration for detecting and enumerating circulating tumor cells (CTCs) to help manage patients with metastatic breast, prostate, and colorectal cancers. The test is also approved by the China Food and Drug Administration for use in monitoring metastatic breast cancer patients.

Working closely with clinicians, clinical investigators and pharmaceutical companies, these technologies are part of the company’s strategic objective to develop companion diagnostics that allow selecting patients more likely to respond to targeted drug treatments, and that accelerate the validation of personalized therapies. 

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Summary

The QA Analyst I is a key member of the Quality Assurance team, and serves as the primary specialist resource for Product Release processes that are critical to our medical device quality system and production environment for the company. Primary responsibilities cover acting as the quality resource responsible for Batch Record review, product release, and working within the change/deviation management and Document management systems (Trackwise and Documentum).  Additional involvement in medical device quality systems operations, including conducting line clearance, printing product labeling, document reviews, etc, as needed or capable. As a member of the Quality Organization this position will have the opportunity to utilize quality skills and experience to help monitor equipment and processes for adherence to established procedures/regulatory compliance; this critical team member may also provide assistance and support to help resolve issues (including product complaint investigation/processing) and complete projects. This position reports to the Manager, Production Quality.

Essential Functions  

1. Perform Product/Batch Record review for both internal and externally produced products to ensure they are thoroughly reviewed, and any discrepancies corrected prior to batch release.
2. Perform Batch Release - Ensure all QA transactions within SAP are performed efficiently and that required Certificates of Conformance/Analysis are issued accordingly.
3. Assist with manufacturing, QC and Product Support when necessary to resolve manufacturing issues, deviations/non-conformances.
4. Provide Quality input and oversight to the CAPA process related to production related issues.
5. Provide review and approval of assigned documents within Documentum requiring Quality Assurance approval.
6. Assist in the management of Change Controls for the TrackWise Change Management Processes within operations. 
7. Support and assist with internal and external audits.
8. Assist in the development of new SOP’s and revise existing SOP’s where required to streamline and improve processes and maintain compliance with regulatory requirements.
9. Participate in Material Review activities, meetings and report-outs to monitor and disposition materials
10. Provide overall quality support for Manufacturing, Operations, QC, and external manufacturing including but not limited to:

• Line Clearance and close-out activities
• Label review and label printing where required
• Raw material record review and release
• Batch record review and release of products intermediate and final products
• Batch record review for externally produced products
• Production related Deviations/non-conformances and CAPA’s
• Review of daily verification forms, temperature records etc.
• Review of QC stability results
• Review of Environmental Monitoring activity including water testing
• Quality walk-through and oversight of storage and production areas

11. Perform other quality related duties as assigned.

Required Education and Experience

·      Bachelor’s degree or two year associates degree with relevant experience.

·      3 to 5 years of experience in a medical device or regulated industry.

·      Fundamental understanding of quality methods, tools, and concepts.

·      Basic understanding of CAPA, Deviations/Non-conformances.

·      Familiar with medical device regulations, Good Manufacturing Practice requirements, and standards such as 21 CFR Parts 820, and ISO 13485.

·      Proficient with MicroSoft Office tools such as excel spreadsheets and Microsoft Word. 

Preferred Education and Experience

 ·   Certification (i.e. ASQ, etc) in a Quality discipline (CQE, CQA, CQM)

·    Experience in In vitro Diagnostics, Medical Device manufacturing or molecular diagnostics environment; background in reagent manufacturing would be a strong plus.

·    Experience working with Electronic Quality System tools such as TrackWise.

·    Experience working with electronic document management systems (EDMS) such as Documentum. 

Technical acumen

·    Strong problem solving/analytical skills

·    Thoroughness and detail-oriented

·    Excellent Written/Verbal communication skills

·    Demonstrates prioritization and time management skills

The Quality Analyst is an individual contributor position working cross-functionally within QA and other departments to maintain compliance with the FDA QSR and ISO 13485. 

Other Duties

Please note this job description is not designed to cover or contain a detailed / comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.  Work Environment

This job operates in a professional office setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, fax machines, etc. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands

This is an office-based position which will some activities in a production environment as well as lab setting; general movement is required. This would require the ability to stand for extended periods and to lift files, open filing cabinets, and bend or stand as necessary.

Position Type/Expected Hours of Work

This is a full time, exempt, professional-level position. Typical days and hours of work are Monday through Friday, 8:30 a.m. to 5:00 p.m.

Travel

This position does not typically require travel.