Quality Assurance Specialist
Quality Specialist is responsible for supporting and working within the Product Assurance Release team and Quality Inspection team. Quality Specialist supports and works with Operations and other Quality groups to ensure acceptance activities are met and records are maintained. Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensure that deadlines are met on time and within budget. Limited interface with other departments and business or marketing partners. Work independently with limited supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.
2nd shift positions (6 openings):
3 people will initially train in PR, the other 3 in QI and then we will rotate them. Hours will be the same for all 6 hires - 2:30pm-11pm. However, due to resource constraints on 2nd shift, we need to train all (or the majority) of these new hires on 1st shift (6am-2:30pm), therefore they will hopefully be flexible. Additionally, the 6 people above need to be flexible in the event we need them to work different shift hours, which could be 530 PM - 2 AM. We will also be asking if any of the 6 people would be available and interested in working on 3rd shift, should production needs change and a 3rd Quality shift be required, but we don't need everyone to say yes to 3rd shift, therefore, it will not be a deal breaker if candidates can't commit.
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
--Performs batch record review of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits.
--Performs approval and final release of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits using the EDMS and ERP system.
--Conducts compliance audits of less complex documentation & data.
--Assists in internal and/or walk around audits.
--Serves as QA interface with limited responsibilities.
--Prepares data packages for external customers and regulation bodies.
--Performs compliance activities such as QA Holds, room releases, at-risk processing, initiating non-conformances, etc.
--Assists in new employee training.
--Performs initial troubleshooting activities.
--Assists in maintenance & reporting of department metrics.
--Review and assess the appropriateness of document changes in accordance with internal procedures with oversight and guidance.
--Inspects raw materials, components, and finished kits.
--Maintains inspection and lab records.
--Perform laboratory maintenance per written protocols (e.g. cleaning, equipment and maintenance calibration).
--Identifies and performs general process improvements
--Basic knowledge of FDA regulations and ISO requirements
--General knowledge of basic measurement devices
--Written and verbal communication skills
--Basic computer skills
--Basic math skills
--Basic knowledge of QSR & ISO requirements
--Typically requires High school and 4-6 years related experience or AA and 2-4 year related experience or BS and 0-2 years related experience
High school--$20.50/hour + 10% night differential
AA--$22/hour + 10% night differential
Bachelor's--$24/hour + 10% night differential
Please email me your resume at email@example.com.
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