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Investigation Specialist

Pfizer


Location:
New York, NY 10029
Date:
04/17/2018
2018-04-172018-05-18
Pfizer
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Job Details

ROLE SUMMARY



The Investigations Specialist is responsible for activities related to the investigations/deviations/CAPA process. Responsibilities include conducting the investigations, writing summary reports, suggesting and implementing appropriate corrective actions, and verifying effectiveness of CAPA.







ROLE RESPONSIBILITIES



The essential functions of this position include, but are not limited to:







+ Write investigations (QARs and event reports) related to manufacturing, packaging, warehouse, facility and engineering, stability (Quality Notification Reports, QNRs), internal and external complaints etc. Conduct Root Cause Analysis (RCA) to evaluate each of the possible causes in order to determine the true root cause. Propose appropriate corrective actions and preventive actions (CAPAs) as well as CAPA effectiveness checks.



+ Complete investigations within established time frames.



+ Evaluate incidents and submit for QA review.



+ Lead investigation meetings.



+ Complete assigned CAPAs within established time frames.



+ Engaging subject matter experts to assist in investigations as applicable.



+ Assist management during FDA audits with respect to investigations and CAPAs.



+ Develop protocols for emptying, inspection, and/or repackaging of lots associated to investigations.



+ Communicates as appropriate with other Pfizer Sites and suppliers.



+ Communicate status of investigations and escalation issues as appropriate.



+ Use Operational Excellence tools (M1 to M4) as part of troubleshooting and investigation process.



+ Assist in the development of policies, procedures and protocols for investigation-related practices.







QUALIFICATIONS



Education:







+ Bachelor degree in Pharmacy, Engineering, or Science



+ Spanish and English proficiency







Experience:







+ 2 to 4 years of related manufacturing/packaging experience



+ Strong knowledge of cGMPs



+ Strong knowledge of Operational Excellence (OPEX) tools (Green Belt or Black Belt)



+ Knowledge of Trackwise (QTS), EAMS, PDOC's, Plateau, SAP







**OTHER REQUIREMENTS:**







+ Technical Skills



+ Technical writing



+ Analytical skills



+ Computer Literacy



+ Strong knowledge of manufacturing and packaging processes and equipment



+ Working knowledge of Microsoft Word, Excel and PowerPoint



+ Competencies



+ Managing multiple priorities



+ Communication skills



+ Negotiation skills



+ Leadership



+ Innovation and creativity



+ Strategic Thinking and problem solving



+ PHYSICAL/MENTAL REQUIREMENTS



+ The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 20 pounds occasionally. Generally work is performed in an office and or manufacturing/packaging environment.







**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: April 27, 2018**



+ 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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