Pfizer Quality Investigations Senior Manager in McPherson, Kansas
Manage 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.
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.
Requires a bachelor 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.
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Other Job Details:
- Last Date to Apply for Job: September 14, 2018Eligible for Relocation Package - YES
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.