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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.
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.
1) Write exception reports regarding plant issues and critical defect audit failures. The main focus will be in Microbiology and Environmental Monitoring but may include investigation of Production, Incoming Quality, Chemistry, Engineering, Validation, and other personnel necessary to complete the investigation.
2) Conduct personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue.
3) Evaluate corrective actions in regards to trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur.
4) Perform follow-up activities to coordinate the completion of corrective and/or preventive actions. Perform effectiveness checks for investigations.
5) Remain current in regulatory expectations and industry practices regarding investigations and CAPA.
Quality Investigations Engineers must have the ability to understand and problem solve in an environment that is focused heavily on Chemical and Biological issues. This person needs to understand the concepts incorporated in Quality Assurance in a GMP environment. Advanced skills in statistics are required to effectively analyze trends.
Requires bachelor's degree in scientific, engineering, or business field. CAPA, investigations, or manufacturing quality assurance experience in pharmaceutical industry or equivalent manufacturing field, 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.
Must be capable of organizing data from multiple sources, extracting key information and documenting investigation detail into the exception tracking software. Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access and Paradox) Experience using data analysis computer tools and statistical analysis is preferred. Experience working in a cross-functional, matrix environment. Six Sigma Green Belt preferred.
The position requires the ability to work in interdepartmental environments focused on root cause engineering. The individual must be able to think and problem solve in group situations that require tight time frames. The most challenging aspect of the position will be to get all the necessary data from different departments in a set time-line.
This position will be responsible for completing investigations in a timely manner. Independent action and sound decision making are essential for success in the position as decisions can impact product release and compliance with GMP.
Other Information - Internal
Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.
Legacy Hospira Grade 14
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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