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GTx QA Sr. Doc Control Associate

Pfizer Inc. – Sanford, NC

ROLE SUMMARY

This role will be the Senior Document Control Associate for Quality Assurance for the new Stage 2 Gene Therapy Facility in Sanford, NC.

The Sr. Document Control Associate is responsible for document management system administration and end user support. The individual manages document workflows within the Pfizer global electronic document management system and provides administrative approval for document promotions. This individual provides guidance to document authors on document workflow and provides input on document standards and requirements. In addition, the Sr. Associate provides technical writing services to supported operations.

ROLE RESPONSIBILITIES

  • Responsible for knowing, understanding and acting in accordance with Pfizers values and our OWNIT culture.
  • System Owner for the Pfizer GTx Stage 2 Document Control Program. Ensures document management program adheres to cGMPs and Pfizer policies.
  • Manages documents through various workflows, ensures document properties are appropriately set, and provides administrative approval for document promotion.
  • Provides technical writing support such as creating/revising Standard Operating Procedures and child documents (job aids, skill checks, knowledge assessments) using site standard templates.
  • Provides end user training for Pfizer document management system and first-level end user support.
  • Coordinates and provides any GTx 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 Stage 2 Document Control process.
  • Interfaces with other parts of the organization such as Operations, Quality management, and other Document Control departments on site (e.g. Vaccines). This may include being involved in the initiation, design and execution of several concurrent Document Control projects.

QUALIFICATIONS

  • 5 -10 years of manufacturing, quality or engineering experience with a BS/BA Degree.
  • 2 -7 years of manufacturing, quality or engineering experience with a MS/MA Degree in Science/related field.
  • 0 -1 years of manufacturing, quality or engineering experience with a PhD in Science/related field.
  • Biotech or pharmaceutical industry experience is highly preferred.
  • Demonstrated technical writing experience is desirable.

PHYSICAL/MENTAL REQUIREMENTS

Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be typical.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Limited travel for the position; no more than 15% traveling.

It will be necessary to work in areas that require aseptic gowning.

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 providers 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.

  • Last Date to Apply for Job: 7/31/2019
  • Eligible for Employee Referral Bonus
  • Eligible for Relocation Package
N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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