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Quality Investigations Engineer

Pfizer


Location:
McPherson, KS 67460
Date:
12/13/2017
2017-12-132018-02-09
Pfizer
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Job Details

**ROLE SUMMARY**



Act as a Corporate and plant resource to standardize investigations through process evaluation, template development and training. Provide quality engineering consulting (to include investigations, CAPA and training) to support Corporate and plant activities. Evaluate process/procedure changes as necessary and assure changes are implemented in associated plant procedures. Track, trend, and act on CAPA program requirements in a systematic and effective way to assure timely closure. Promote consistency in investigation practices across Corporate and plants. Review and evaluate sensitive, confidential information and develop recommendations for use by plant Quality and Corporate Quality management. Actively participate in Six Sigma and LEAN projects.







**ROLE RESPONSIBILITIES**







+ Write exception reports regarding plant issues and critical defect audit failures. This may include investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other personnel necessary 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 preventive actions to eliminate the potential for non-conformities to occur.



+ Perform follow-up activities to coordinate the completion of corrective and/or preventive actions. Perform effectiveness checks for investigations.



+ Remain current in regulatory expectations and industry practices regarding investigations and CAPA.







**QUALIFICATIONS**







+ Requires a bachelor's degree in scientific field or equivalent pharmaceutical experience.



+ Requires 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 communication, 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 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.







**EEO & Employment Eligibility**



Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Last Date to Apply for Job:** December 27, 2017



Eligible for Relocation Package







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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