Quality Investigations Engineer - Engineering (G14)
Location:
McPherson, Kansas
Posted:
September 09, 2016
Position Type:
Full Time
Category:
Engineering
Reference:
1035421


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Initiate events as well as investigate and write all high and medium level investigations regarding plant issues and critical defect audit failures. This may include investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation and other personnel as necesary to complete the investigation. Conduct personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue. Evaluate corrective actions in regards to trends. Identify and implement preventative actions to eliminate the potential for non-conformities to occur. Perform follow-up activities to coordinate the completion of corrective and/or preventative actions. Perform effectiveness checks for investigations. Design studies as needed to gather critical data for investigation and/or corrective actions. Track, on a daily basis, the progress of all investigations. Report on progress in the weekly MRB and Batch Release meetings. Remain current in regulatory expections and industry practices regarding investigations and CAPA.

Qualifications
-Requires a bachelor's degree in scientific field or equivalent pharmaceutical experience
-Requres a minimum of 2-5 years of CAPA, investigations or manufacturing quality assurance experience, or a minimum of 6-8 years manufacturing/technical experience in a pharmaceutical or related GMP environment.
-Strong oral, written communications, presentation and interpersonal skills.
-Capable of interfacing with multiple levels of people within the organization including Corporate management, third party customers, and plant personnel.
-Superior technical writing and problem solving skills required and in-depth knowledge of exception documentation procedures and requirements.
-Must be capable of organizing data from the multiple sources, extracting key information and documenting investigation detail into SmartCAPA software.
-Must have project management or project development experience within pharmaceutical, medical device or related healthcare industry with demonstrated successful results.
-Experience with MS Word, Excel Access and Paradox
-Experience using data analysis computer tools and statistical analysis is preferred.
-Experience in working in a cross-functional, matrix environment.
-ASQ Certified Quality Engineer and Six Sigma Green Belt preferred.
-The grade will be dependent on the candidate's qualifications and experience.
A little about us:
Join Pfizer in our mission to find sustainable solutions to the most urgent health care challenges of our time. Your service is needed.

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