Quality Assurance Specialist II

Would you like to join an innovative team driven by a bold vision –   It is an extraordinary time for Standard Bio Tools. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.
At Standard Bio Tools, we are building a positive culture where our people can do the best work of their careers, informed and influenced by our core behaviors:  
• Keep customers front and center in all of our work  
• Be accountable and deliver on commitments  
• Drive continuous improvement  
• Be collaborative and work as one team: fostering communications in a learning, coaching, and helpful environment

This position will report to the Manager, Quality Assurance and is responsible for completing onsite quality activities that support business operations, including product and material release.  This position also supports other quality systems activities including customer complaints, CAPAs, supplier quality, nonconformances, training, document control, and audits. The individual in this role will be relied upon to ensure the compliance and effectiveness of the quality system for their role as defined in respective procedures.#

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Key Job Responsibilities
* Attend standup meetings for manufacturing, lab, and QC
* Review and release of incoming materials
* Review analytical QC (aQC) and functional QC (fQC) activities
* Review testing and batch records associated with product release
* Review Equipment Maintenance and Calibration Records
* Monitor and approve non-conformance management steps
* File and maintain integrity of quality records
* Use electronic documentation systems (eDMS, eQMS) to process Change Orders and Quality events
* Create, revise and drive release of documents and templates
* Update databases and spreadsheets used to track, monitor, and report department activities
* Support internal and external audit activities
* Support quality issues and quality metrics related activities
* Conduct assay study review and release to support laboratory services
* Monitor and support development of training plans based on roles defined in procedures
* Support Customer Complaints Program
* Support CAPA Program
* Support Supplier Quality Program by monitoring performance and managing Supplier Corrective Actions and supplier self-questionnaires
* Participate in continuous improvement projects
* Comply with applicable regulatory requirements, company policies, operating procedures, processes, and task assignments.  (e.g. 42

CFR
493, 21

CFR
820, ISO 9001, ISO 13485, ISO 15189)
* Other duties, as assigned #
** Qualifications
* **
* Education:

** Bachelor’s or Associate’s degree in a Scientific or Technical field preferred but not required.
*
* Skills and Experience:

** 2-5 years in Quality or Operations, preferably within a related regulated field (pharma or medical device)
** Desired experience with:
*** Electronic document management
* Electronic Quality Management workflow
* Change control systems
* Good documentation practices
* Excellent attention to detail
* Intermediate knowledge of FDA CDRH, ISO, CAP and/or CLIA regulations. (e.g. 42

CFR
493, 21

CFR
820, ISO 9001, ISO 13485, ISO 15189)
* Strong computer skills with word processing, spreadsheets, and software tools in support of preparing technical documentation and metrics
* Ability to work independently while following Standard Operating Procedures (SOPs)
* Strong verbal and written communications
* Multitasks, prioritizes and meets deadlines in timely manner
* Attention to detail in preparation of materials and their review #
** Work Environment
*** Ability to be on site 4-5 days a week
* Work is in typical office environment and occasional work in a typical laboratory environment with personal protective equipment use required
* The work environment may include, but is not limited to, the following hazards: chemical, electronic, mechanical, biohazard waste, and infectious materials
* While performing the duties of this job, the employee is frequently required to stand and walk. The employee is regularly required to…