Pride Global
The Engineering Team at Russell Tobin & Associates
is hiring a
Quality Engineer
for an exciting pharmaceutical organization near Raleigh, NC. Responsibilities Initiate, investigate and support quality Events, Complaints and CAPA's and SCARS. Coordinate, and maintain customer complaint & CAPA management system, validations for all departments, along with the Calibration Program and the Environmental Monitoring Program. Write and implement methods and procedures for supporting the quality management system. Review and approve quality assurance procedures and reports. Coordinate the implementation of process controls to support manufacturing operations. Review and approve methods and procedures for supporting the quality management system. Participate in investigation, resolution, and prevention of product and process non-conformances. Provide support for validations. Facilitate audits (both internal and supplier) and support compliance with applicable Regulatory Quality System standards. Participate in supporting quality decisions. Support, coordinate and maintain service provider qualification and monitoring. Conduct root cause analysis investigation and perform risk assessment and evaluations to identify appropriate corrective action. Conduct quality assurance tests and performs statistical analysis to assess the level of control and manage product quality risks. Employ Quality Engineering tools and techniques to develop, align and optimize systems and processes. Write reports and facilitate its use for supporting the quality management system. Performs other duties as assigned by Manager. Requirements
Bachelor's degree in natural/life science field with knowledge and experience on one of the following areas: medical device, biotech or pharma. 3-5 years experience in quality engineer, QA or similar role 3-5 years auditing experience - conducting and supporting Experience with root cause analysis as it related to investigations and CAPAs GMP knowledge ERP system experience Working knowledge of ISO 9001:2015 Standard. Must have excellent communication skills
Additional Details:
Onsite position Schedule: Monday-Friday - 7:30am-4pm Position Type: 1 year contract with potential for extension / conversion. Pay rate approved up to $44/hr
Must be authorized to work in the United States. Russell Tobin offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors. APPLY NOW!
#RTA #rta-zr #JD-SCIENCE
is hiring a
Quality Engineer
for an exciting pharmaceutical organization near Raleigh, NC. Responsibilities Initiate, investigate and support quality Events, Complaints and CAPA's and SCARS. Coordinate, and maintain customer complaint & CAPA management system, validations for all departments, along with the Calibration Program and the Environmental Monitoring Program. Write and implement methods and procedures for supporting the quality management system. Review and approve quality assurance procedures and reports. Coordinate the implementation of process controls to support manufacturing operations. Review and approve methods and procedures for supporting the quality management system. Participate in investigation, resolution, and prevention of product and process non-conformances. Provide support for validations. Facilitate audits (both internal and supplier) and support compliance with applicable Regulatory Quality System standards. Participate in supporting quality decisions. Support, coordinate and maintain service provider qualification and monitoring. Conduct root cause analysis investigation and perform risk assessment and evaluations to identify appropriate corrective action. Conduct quality assurance tests and performs statistical analysis to assess the level of control and manage product quality risks. Employ Quality Engineering tools and techniques to develop, align and optimize systems and processes. Write reports and facilitate its use for supporting the quality management system. Performs other duties as assigned by Manager. Requirements
Bachelor's degree in natural/life science field with knowledge and experience on one of the following areas: medical device, biotech or pharma. 3-5 years experience in quality engineer, QA or similar role 3-5 years auditing experience - conducting and supporting Experience with root cause analysis as it related to investigations and CAPAs GMP knowledge ERP system experience Working knowledge of ISO 9001:2015 Standard. Must have excellent communication skills
Additional Details:
Onsite position Schedule: Monday-Friday - 7:30am-4pm Position Type: 1 year contract with potential for extension / conversion. Pay rate approved up to $44/hr
Must be authorized to work in the United States. Russell Tobin offers eligible employees comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors. APPLY NOW!
#RTA #rta-zr #JD-SCIENCE