Pfizer Quality Compliance Coordinator in McPherson, Kansas
Coordinates and oversees Quality activities directed towards assessing site compliance to all appropriate standards, specifications, contractual requirements, and government regulations, both internally and externally. Provides written assessment reports in association with auditing.
Schedule of assessments
Train and monitor plant personnel to support program
Track completion of audit events ensuring completion of schedule and closure of assessments.
Training for all controlled environments within the facility.
Responsible for utilizing the Internal Assessment program for implementation of continuous improvement throughout the facility.
Assisting in Third Party and Regulatory audits as necessary. Activities include:
Track corrective action taken as result of audit
Maintain database, proofbook and insure completion of action items.
Tracking and trending metrics for Internal Assessment program to be reported in CAPA (Corrective and Preventive Action) Management Review and Key Performance Indicators.
6-8 years of experience in the Pharmaceutical industry, with a minimum of 2 years in Quality.
Strong oral, written, communication, presentation and interpersonal skills.
Working knowledge of PC and software (MSOffice, SAP).
Production and Laboratory knowledge preferred.
ISO Lead Auditor or ASQ Certified Quality Auditor certification is preferred.
Competence in college level mathematics and/or statistics preferred.
An audit or assessment is only a sampling of the quality systems employed by an organization at a given point in time. Significant deficiencies may not be discovered at the time of the audit or assessment, which may place Pfizer at a regulatory risk. Audits and assessments require a creative approach in order to identify true system deficiencies. The ability to navigate effectively through processes is vital in order to identify the system deficiencies in complex environments.
Required to track and trend data in order to report department metrics to management. Experience with statistical and data analysis preferred. Must be capable of organizing and analyzing data from multiple sources, and extracting key information to achieve goals.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Adherence to aseptic gowning requirements.
Flexibility in scheduling to observe processes and practices in site with 24-7 shifts.
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.
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: June 29, 2018
This job is Hospira Exempt US Grade: 13
Relocation Assistance to be provided
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.