Associate, GLP Pfizer Pearl River

Title Associate, Glp
Date 15 January 2021
Company Pfizer
City Pearl River

Short Description :

Assist staff in the use of quality system SOPs Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations Consult with managers in various groups to develop ,…

Full Description :

ROLE SUMMARY

This position supports the Vaccine Research and Development (VRD) Quality and Compliant Operations (QCO) Director of Compliance in implementation of Quality Systems in VRD consistent with CFR and EMA guidelines for bioanalytical laboratories and GMP release testing. The incumbent is responsible for analysis and reporting on status of VRD Quality Systems to QCO management and VRD management as directed. This position also supports monitoring of laboratory quality for VRD and ensuring inspection readiness for audits by MQA or inspections by external groups.

The candidate will have comprehensive knowledge of GLP/GCLP/GMP principles and concepts and work with the supervisor and VRD management to identify gaps and areas of opportunity to support colleague ability to accurately and consistently apply principles, procedures, and processes to ensure compliance with VRD Quality Systems.

ROLE RESPONSIBILITIES

  • Perform gap analysis to Identify and track gaps/compliance risk regarding quality, compliance and inspection readiness.
  • Assist in development and implementation of preventative action.
  • Develop good working practices/guidelines to work as tools to assist staff in the use of quality system SOPs.
  • Consult with managers in various groups to coordinate and implement decisions made regarding compliance practices.
  • Assist Director of Compliance in VRD in providing compliance direction to all colleagues in GLP/GCLP/GMP issues/matters.
  • Assist Director of Compliance in VRD in development and maintenance of appropriate processes for on-boarding and off-boarding for all VRD. Ensure compliance with established processes and proper documentation.
  • Consult with managers in various groups to develop appropriate curriculum.
  • Coordinate curriculum management and proactively identify roles within VRD that are impacted by changes to ensure colleagues and contractors are assigned the appropriate training including new hire training, and ensure training compliance.
  • Support inspection readiness by ensuring Quality System documentation is inspection ready.
  • All other job duties as assigned.

BASIC QUALIFICATIONS

  • Minimum 2+ years proven compliance experience with an Associate’s Degree in a Science.
  • Fundamental knowledge of and experience with GLP/GCLP/GMP.
  • Ability to multi-task and prioritize assignments.
  • Strong communication (written and verbal).
  • Computer and systems skills: industry enterprise systems, MS Office applications and a solid understanding and use of relational databases and knowledge of Sharepoint.
  • Experience in electronic data systems (e.g. P2L, GDMS, GNOSIS, Pedagogue) preferred.
  • Highly skilled in precision checking and verifying data and information with low error rate.
  • Sharp eye for details while maintaining work overview.

PREFERRED QUALIFICATIONS

  • Bachelor Degree in Science preferred.
  • Some working knowledge of setting up and monitoring/QA of routine GMP processes preferred.

Other Job Details:

  • Last Date to Apply for Job: February 5, 2021
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES

#LI-PFE

Sunshine Act

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 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 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 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.

EEO & Employment Eligibility

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. 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. is an E-Verify employer.

Quality Assurance and Control

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