POSITION 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.
ESSENTIAL FUNCTIONS:
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.
PRINCIPAL WORKING RELATIONSHIPS
Inside the Company:
Extensive contacts with Planning, Manufacturing, Packaging, Purchasing, Quality Control, Quality Assurance, Engineering, Technical Services and/or EHS.
Outside the Company:
Contact with other Pfizer sites as well as external suppliers.
BASIC QUALIFICATIONS
Bachelor degree in Pharmacy, Engineering, or Science
Spanish and English proficiency
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
PREFERRED QUALIFICATIONS
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 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.
ENVIRONMENTAL REQUIREMENTS:
Supports the Company’s Environmental Programs following established policies and procedures, and Corporate Environment Policies.
Will assure that any waste (hazardous, non-hazardous or special waste) generated as part of his/hers responsibilities are handled in compliance with applicable environmental regulations and in accordance to establish SOP’s for handling waste.
Will report any malfunction in emissions control equipment to supervisor and/or Environmental Engineer and Environmental Manager.
Participate in the maintenance of storm water pollution and/or spill prevention program in compliance with applicable environmental regulations and in accordance to establish SOP’s and reports any failure in spill control system and/or any spill that may occur.
Last Date to Apply:March 3rd , 2020
Additional Location Information:Vega Baja, Puerto Rico
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Sunshine Act
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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.
Manufacturing
