Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Charlotte, NC
View more jobs in North Carolina
View Similar Jobs

Job Details

Quality Specialist

Company name
NES Global Talent

Salary
35

Location
Charlotte, NC

Apply for this job






20 hit(s)  

Profile



Job Description
- Job Description:  QUALITY SPECIALIST\r
\r
Primary responsibilities include day to day management of the plants Quality Management System (QMS) to ensure continuing compliance with site policies, procedures and ISO 9001 requirements \r
\r
This position reports to the site Quality Assurance Manager and will work closely with  Plant Operations, Laboratory and Maintenance personnel as well as Corporate Regulatory Affairs. \r
\r
- Develop, maintain and improve the site QMS; ensure compliance with site policies/procedures and ISO 9001\r
- Assist in preparing the site for transition to ISO 9001:2015\r
- Revise and improve site QMS as needed to meet the requirements of RC 14001 and achieve formal certification (will partner with site Safety Manager in all activities related to RC 14001 certification)\r
- Create or revise Quality Manual and/or Standard Operating procedures as needed\r
- Manage Corrective Action/Preventive Action (CAPA) system; drive prompt response to open CAPAs and assure timely closure\r
- Verify effectiveness of corrective actions\r
- Establish process control plans\r
- Evaluate process capabilities using statistical analyses\r
- Perform Gage R&Rs\r
- Assist Purchasing with follow-up and resolution of issues with incoming raw materials and supplier corrective actions\r
- Actively lead/participate in investigations to determine root cause of non-conforming material and appropriate material disposition\r
- Conduct internal audits; assist with site audits from external sources\r
- Prepare customer responses to audit findings and customer complaints\r
- Assist with set up and transition of site documentation from paper based system to electronic document management system\r
- Prepare and conduct site QMS management review meetings\r
- Prepare monthly reports for KPIs\r
- QA oversight and support of production, testing and shipment of API\r
- Review production lot records and analytical test results\r
- Review discrepancies and change control for potential product/regulatory impact\r
- Release product for shipment and complete pre-shipment inspections\r
- Revise and review standard operating procedures\r
- Assist with regulatory and customer audits\r
- Conduct supplier audits\r
- Review validation protocols and summary reports\r
- Monitor key product parameters for trends; initiate Out of Trend investigations as appropriate\r
- Review OOS investigations and assure errors are resolved and appropriately documented; assure data integrity in reporting of finished lot test results\r
- Perform other quality related duties as identified\r
\r
Requirements:\r
\r
- Bachelor degree in Engineering, Chemistry or other relevant field\r
- 10 years demonstrated leadership in development, implementation and management of QMS (ISO 9001 or other nationally recognized standard compliant)\r
- Experience with ISO 14001 or RC 14001 preferred\r
- Experience in a chemical manufacturing environment preferred\r
- Lean Sigma training and the ability to utilize these tools for driving system improvements preferred\r
- Trained ISO 9001 and/or cGMP auditor; minimum 5 years auditing experience.Lead Assessor training preferred\r
- Experience with management systems compliant with RC 14001 preferred\r
- Ability to multi-task, prioritize and be self-directed; able to manage competing priorities and deliver results in a timely manner\r
- Effective verbal and written communication skills are a must\r
- Strong problem solving skills\r
- Works well with all employees at all levels of the organization; team oriented\r
- Decisive and able to make informed decisions that align with regulatory requirements and company policies\r
\r
Established in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.

Job Requirements
Primary responsibilities include day to day management of the plants Quality Management System (QMS) to ensure continuing compliance with site policies, procedures and ISO 9001 requirements \r
This position reports to the site Quality Assurance Manager and will work closely with Plant Operations, Laboratory and Maintenance personnel as well as Corporate Regulatory Affairs. \r
•Develop, maintain and improve the site QMS; ensure compliance with site policies/procedures and ISO 9001\r
\tAssist in preparing the site for transition to ISO 9001:2015\r
\tRevise and improve site QMS as needed to meet the requirements of RC 14001 and achieve formal certification (will partner with site Safety Manager in all activities related to RC 14001 certification)\r
\tCreate or revise Quality Manual and/or Standard Operating procedures as needed\r
\tManage Corrective Action/Preventive Action (CAPA) system; drive prompt response to open CAPAs and assure timely closure\r
\tVerify effectiveness of corrective actions\r
\tEstablish process control plans\r
\tEvaluate process capabilities using statistical analyses\r
\tPerform Gage R&Rs\r
\tAssist Purchasing with follow-up and resolution of issues with incoming raw materials and supplier corrective actions\r
\tActively lead/participate in investigations to determine root cause of non-conforming material and appropriate material disposition\r
\tConduct internal audits; assist with site audits from external sources\r
\tPrepare customer responses to audit findings and customer complaints\r
\tAssist with set up and transition of site documentation from paper based system to electronic document management system\r
\tPrepare and conduct site QMS management review meetings\r
\tPrepare monthly reports for KPIs\r
•QA oversight and support of production, testing and shipment of API\r
\tReview production lot records and analytical test results\r
\tReview discrepancies and change control for potential product/regulatory impact\r
\tRelease product for shipment and complete pre-shipment inspections\r
\tRevise and review standard operating procedures\r
\tAssist with regulatory and customer audits\r
\tConduct supplier audits\r
\tReview validation protocols and summary reports\r
\tMonitor key product parameters for trends; initiate Out of Trend investigations as appropriate\r
\tReview OOS investigations and assure errors are resolved and appropriately documented; assure data integrity in reporting of finished lot test results\r
•Perform other quality related duties as identified\r
Requirements:\r
•Bachelor degree in Engineering, Chemistry or other relevant field\r
•10 years demonstrated leadership in development, implementation and management of QMS (ISO 9001 or other nationally recognized standard compliant)\r
•Experience with ISO 14001 or RC 14001 preferred\r
•Experience in a chemical manufacturing environment preferred\r
•Lean Sigma training and the ability to utilize these tools for driving system improvements preferred\r
•Trained ISO 9001 and/or cGMP auditor; minimum 5 years auditing experience.Lead Assessor training preferred\r
•Experience with management systems compliant with RC 14001 preferred\r
•Ability to multi-task, prioritize and be self-directed; able to manage competing priorities and deliver results in a timely manner\r
•Effective verbal and written communication skills are a must\r
•Strong problem solving skills\r
•Works well with all employees at all levels of the organization; team oriented\r
•Decisive and able to make informed decisions that align with regulatory requirements and company policies

Company info

NES Global Talent
Website : http://www.nesglobaltalent.com

Company Profile
We provide a complete range of global talent solutions to the oil and gas, power, infrastructure, chemical, life sciences and rail sectors worldwide. Offering far more than a traditional recruitment service, our comprehensive set of guaranteed staffing solutions ranges from payroll administration to full recruitment process outsourcing. Established over 35 years ago, with more than 40 offices in 26 countries and over 500 specialist staff and discipline specific consultants, we are able to support our clients with all of their global talent requirements and our candidates with finding the best in global job opportunities.

Similar Jobs:
Quality Associate - 3rd Shift
location Fort Mill, SC
\n\nJob Description\nSchaeffler, a global automotive & industrial supplier, is seeking a Quality Associate for our FM2 Facility in Fort Mill, SC.  \r\rKey responsibilities include but not limited to:\r\r\rEnsure metrics, processes...
Validation Manager
location Monroe, NC
\n\nJob Description\nIf you are a Sr. Validation Engineer and are ready to take the next step, please apply! We want someone who is ready to work hands on and will build this department from the ground up. \r\rJob Title: Validatio...
Quality Engineer
location Charlotte, NC
Description OTTO Environmental Systems North America, Inc. (OESNA), located in Charlotte North Carolina, is a leading manufacturer of injection molded residential and commercial waste containers for markets across the United State...
I was very pleased with the ChemistryCrossing. I found a great position within a short amount of time … I definitely recommend this to anyone looking for a better opportunity.
Jose M - Santa Cruz, CA
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ChemistryCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ChemistryCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ChemistryCrossing - All rights reserved. 169