What are the responsibilities and job description for the Quality Assurance Specialist position at MOLECULAR DESIGNS?
Job Details
Description
The Quality Assurance Specialist is responsible for supporting the Director of Quality with implementing and maintaining all aspects of the quality management system. This position requires a person to perform various tasks (but not limited to) within the quality department including Documentation Control (manual and electronically), Corrective Actions, Nonconforming Product, assist with creation of Device Master Records, control of Device History Files, Quality Metrics and SOP/Work Instruction Development.
Responsibilities:
- Monitor quality containment on non-conformances by means of effective quarantine and timely disposition.
- Lead and assist in engineering change control.
- Author Work Instructions, SOP Revisions where applicable.
- Assist with creation of Device Master Records such as routers, master cross references, and bill of materials within the ERP system.
- Maintain Device Master Records and Device History Records as well as other quality system documents such as training records, monitoring records, authorized signature lists, etc.
- Assist with new part number assignment process by creating new part numbers within ERP system for design teams and Marketing department.
- Assist with product release and create inspects in the ERP System (Netsuite)
- Assist with processing Instructions for Use and all labeling intended for domestic distribution.
- Assist with the maintenance of the company QMS web-based software to ensure the most current document revisions are available at all points of use,
- Assist with leading weekly change control meetings and processing of change orders within the Greenlight Guru.
- Provide and maintain weekly/monthly and quarterly quality metrics.
- Complete various projects as assigned by the supervisor in addition to general filing and copying.
Qualifications
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Bachelor’s Degree in biology or related sciences preferred
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1-2 years of experience in quality preferably in biotechnology/ pharma industry preferred.
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Basic knowledge of ISO 13485 and FDA Quality System requirements.
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Applied knowledge of equipment, process, validations as required by FDA Quality System guidelines.
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Ability to analyze data and come to conclusions.
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Excellent oral and written communication skills.
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Ability to follow procedures exactly.
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Incredible organizational skills.
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Self motivated, can work independently without much guidance, team player.
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Proficient in Microsoft Word, Excel, and PowerPoint programs.
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Ability to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities.
