Document Specialist II

Pfizer Andover , MA 01810

Posted 2 months ago

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

Role Summary

This position is looking for a responsible individual to perform lifecycle management of documents. Additionally, this individual will assist in the site record retention program, including record archiving and retrieval as needed.

Role Responsibilities

  • Perform life cycle management of documents such as initiation, document number issuance, approval, distribution, etc.

  • Formatting and editing documents and follow up with authors and reviewers to resolve issues. Ensure document quality and efficacy of document process flow.

  • Manages and facilitates customer requests and provide guidance on QRM document standards and processes.

  • Assists in the site records retention program. Performs records archiving and retrieval as needed.

  • Issues and reconciles batch records per established schedules. Works with Manufacturing and QA to ensure all batch records are accounted for.

  • Issues and reconciles Lab Notebooks, Lab Equipment Notebooks and Logbooks.

  • Write and revise internal procedures to provide closure to process gaps and/or as part of continuous improvement projects.

  • Understands electronic documentation and/or database system processes and communicates system discrepancies that may arise. Communicates issues or suggestions with Management to help rectify or improve the system efficiency

Qualifications

Must-Have

  • High School Diploma or equivalent required.

  • Bachelor's Degree preferred.

  • Proficiency with MS Word and Excel.

  • Proven ability to work independently and also in a team environment.

  • Ability to meet demanding timelines.

  • Strong communication skills.

Nice-to-Have

  • Bachelor's Degree preferred.
  • cGMP experience is a plus but not required.

Physical/Mental Requirements

  • Lifting of boxes

  • Sitting

  • Walking between buildings

Non-Standard Work Schedule, Travel, or Environment Requirements

  • This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise

  • Primarily work from home during current pandemic with transition to office setting.

Other Job Details:

  • Last Date to Apply for Job: 09 OCTOBER 2020
  • Eligible for Employee Referral Bonus
  • #LI-PFE

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.

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.

Quality Assurance and Control

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Document Specialist II

Pfizer