QA Specialist

QA Specialist
Contract Duration 12 Months

Job Description
QA Specialist ensure the quality of manufactured products and processes per standard operating processes(SOP) and GMP (Good Manufacturing Practices).

Job Responsibilities:
Familiar and capable of performing all responsibilities of the Quality Associate.
Subject Matter Expert in one or more specific Quality processes such as incoming inspection and/or change management and/or records (including batch release).
Also support record administration and batch record review, including Certificate of Analysis/Certificate of Conformance creation for material lot release.
QA Specialist will assign labeling and pre-production change requests to Change Management staff aligning experience with project load and complexity.
Process IUO and IVD product labeling and the associated RMS change requests while ensuring compliance with company policies and procedures. Able to navigate complexity and troubleshoot issues with the most complex changes.
Assist labeling change owners and junior staff with the creation of design change plans. Able to leverage subject matter expertise to impart positive impacts on organizational outcomes.
Support change packets per the approved procedures, including analyzing change packets for impact on Device Master Records and the associated maintenance of the DMRs.
Able to independently correct issues and proactively identify future issues.
Leverage expertise to improve future submissions via collaboration with change owners.
Create and maintain the Design History Files per the approved procedures.
QA Specialist will review records for good DHF documentation practices and adherence to the DHF Document Change Control requirements.
Maintain the Master Action Item List, DHF Index, and the DHF History Index.
Assist in the documentation of key processes and departmental procedures and participate in continuous improvement projects as assigned.
Compiles and maintains data used for the creation of department metrics and reports. Able to own key local reporting responsibility and take the lead in areas of expertise, as appropriate.

Experience
BS degree or 3-7 years equivalent experience.

Note:
This position is Non-Exempt.
Hours over 40 will be paid at Time and a Half.

Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

About The Company:
Our client is a globally diversified healthcare company with a central purpose of helping people live their healthiest possible lives. They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets. Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies. They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines.
If you are looking for a great company to work for, look no further because our client has received an average of a four-star rating from its thousands of employees that have written positive reviews on Glassdoor and Indeed.
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