Associate, Document Control

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Nov 18, 2020
Ref
4796743
Required Education
Associate Degree
Position Type
Full time
ROLE SUMMARY

The Associate, Document Control is responsible for document management system administration and end user support at the Sanford, NC site. The role manages document workflows within the Pfizer global electronic document management system and provides administrative approval for document promotions. In addition, this individual provides guidance to document authors on document workflows and provides input on document standards and requirements.

ROLE RESPONSIBILITIES
  • Delivers site-level end user support for the Pfizer Global Supply electronic document management system (DMS).
  • Manages documents through various workflows, ensures document properties are appropriately set, and provides administrative approval for document promotion.
  • Follows the necessary change management processes to maintain compliance during creation of new and revision of existing documents. Review the impact of proposed changes with regards to other support documents.
  • Assures new and revised site documentation/procedures are:
    • Current and consistent with related/similar documents.
    • Meet internal control policies and regulations.
    • Aligned with changes, as required, to current processes based on related investigations, audit responses, developmental, or compendia revisions.
    • Required and not redundant.
  • Coordinates and provides any document-related data for various metric review meetings (e.g. Site Quality Review Team). This includes interpreting document-related data and making recommendations based on findings.
  • Assesses existing situations and suggests improvements in the Document Control process.
  • Interfaces with other parts of the organization such as Operations, Quality management, and other Document Control supporting functions on site.


BASIC QUALIFICATIONS
  • Bachelor's degree in Science, Engineering, Mathematics, English, Communications, Business or related field, with at least 2 years of experience is required. Biopharmaceutical or other regulated environment experience is preferred.

OR
  • AS in Science, Engineering, Mathematics, English, Communications, Business or related field, with minimum of 5 years of experience is required. Biopharmaceutical or other regulated environment experience is preferred.


OR
  • Minimum of 8 years of experience in a training-related or supporting function is required, preferably in a Biopharmaceutical or other regulated environment.

PREFERRED QUALIFICATIONS
  • Able to quickly learn and navigate electronic systems to facilitate routine operation and maintenance of the site documentation system and related processes
  • Able to write clearly and concisely with excellent grammar, good writing skills and communication
  • Skilled in word processing and document formatting; experienced in Microsoft Office applications (Word, Excel, PowerPoint, Visio)
  • Able to effectively proofread documents prepared by self and others for content and others to ensure content and formatting accuracy
  • Demonstrates an ability to adapt to shifting priorities, change, stress and to find appropriate balance between needs of the organization, others and self. Incorporates insights of other people into ongoing work.
  • Able to learn and understand pharmaceutical processes in order to assist with training needs
  • Understanding of cGMP and Safety regulations
  • Strong organizational and communication skills
  • Team based collaborative problem solving


PHYSICAL/MENTAL REQUIREMENTS
  • Position requires desk work and some walking throughout campus to interface with other departments.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • May require occasional evening and weekend hours, as indicated by business and customer needs.


Other Job Details
  • Last date to apply for the job: 12/2/2020


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