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Sr. Quality Assurance Engineer

Job Description

Currently hiring for a Senior Quality Assurance Engineer for a great company in the Boothwyn, PA area!

SKILLS/QUALIFICATIONS:

  • GMP
  • Quality metrics - managing oversight over CAPA's, deviations, etc
  • Manage teams to drive to closure
  • Running CAPA review and Change Control board
  • Knowledge in Viva (electronic system) will be highly preferred
  • Strong root cause analysis background (ASQ, certs)
  • PM background could be helpful (black belt / green belt)
  • BS degree in technical discipline
  • 5+yrs in related industry

JOB DETAILS:

  • This position will champion timely quality issue resolution with a strong focus on root cause identification and effective corrective action implementation to mitigate recurrence of issues
  • Collaborate with Manufacturing and Technical Operations to complete Process Risk Assessment (FMEA).
  • Identify and drive implementation of continuous improvement activities
  • Lead and participate in thorough investigations of quality issues and assure timely resolution
  • Use root cause investigation tools, such as Five Whys or Ishikawa, to assure the true root causes are identified
  • Identify and implement sustainable corrective actions that effectively correct the root cause(s)
  • Ensure investigation and CAPA records are complete, thorough, accurate and timely
  • Assure procedures related to CAPA, statistical techniques, and data analysis and trending are maintained in compliance with regulatory expectations and industry best practices
  • Participate in the sites internal audits to assess the sites state of compliance and to identify gaps
  • Prepare and deliver cGMP training




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-PA-Boothwyn
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Clinical & Scientific, Other
Apply

Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-PA-Boothwyn
Sofia Goris
7173959957
Snapshot
Aerotek
Company:
US-PA-Boothwyn
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Clinical & Scientific, Other
Store Type:

Job Description

Currently hiring for a Senior Quality Assurance Engineer for a great company in the Boothwyn, PA area!

SKILLS/QUALIFICATIONS:

  • GMP
  • Quality metrics - managing oversight over CAPA's, deviations, etc
  • Manage teams to drive to closure
  • Running CAPA review and Change Control board
  • Knowledge in Viva (electronic system) will be highly preferred
  • Strong root cause analysis background (ASQ, certs)
  • PM background could be helpful (black belt / green belt)
  • BS degree in technical discipline
  • 5+yrs in related industry

JOB DETAILS:

  • This position will champion timely quality issue resolution with a strong focus on root cause identification and effective corrective action implementation to mitigate recurrence of issues
  • Collaborate with Manufacturing and Technical Operations to complete Process Risk Assessment (FMEA).
  • Identify and drive implementation of continuous improvement activities
  • Lead and participate in thorough investigations of quality issues and assure timely resolution
  • Use root cause investigation tools, such as Five Whys or Ishikawa, to assure the true root causes are identified
  • Identify and implement sustainable corrective actions that effectively correct the root cause(s)
  • Ensure investigation and CAPA records are complete, thorough, accurate and timely
  • Assure procedures related to CAPA, statistical techniques, and data analysis and trending are maintained in compliance with regulatory expectations and industry best practices
  • Participate in the sites internal audits to assess the sites state of compliance and to identify gaps
  • Prepare and deliver cGMP training




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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