ROLE SUMMARY

The QS Document Systems Associate I plays a key role in supporting Pfizers documentation and compliance infrastructure by managing the creation revision and control of critical documents within the global electronic document management system. This role ensures document integrity and alignment with regulatory expectations site procedures and operational needs.

Responsibilities include initiating and processing change requests updating product batch records and specifications and coordinating implementation of effective dates for approved documents. The associate collaborates with crossfunctional teams including Operations Training Quality Management Technical Operations Engineering Maintenance Utilities and Supply Chain to ensure consistent and accurate documentation across systems such as SAP RDOCS PDOCs and TEAMS.

The role also supports document lifecycle managementsetting document properties promoting documents through workflows and ensuring current Batch records SOPs Job Aids and Forms are maintained at the site. Additional duties include managing contingencies performing document audits providing technical writing and proofreading support and serving as a sitelevel SME and trainer for the Document Systems.

The associate contributes to project deliverables related to document creation ensures deadlines are met and acts as a backup in records management tasks including reconciliation archival and logbook maintenance. They also support regulatory inspections and audits through preparation and timely delivery of required documentation.

ROLE RESPONSIBILITIES

• Manage creation revision and control of documents within Pfizers global electronic systems (RDOCS SAP HPI TEAMS PDOCs) ensuring compliance with regulatory and site standards.

• Perform technical writing and editorial updates to batch records specifications SOPs and supporting documents.

• Align and implement updates to product batch records specifications and SOPs assigning effective dates and ensuring accurate version control.

• Print assemble and issue production batch records based on manufacturing schedules adjusting for reworks or changes as needed.

• Collaborate with crossfunctional teams (Operations Quality Engineering Labs Training Supply Chain) to support document accuracy and alignment.

• Maintain restricted list numbers and manage related documentation obsolescence and deletion actions.

• Execute and prioritize multiple projects develop work plans and meet task deadlines with minimal supervision.

• Participate in periodic reviews and continuous improvement efforts.

BASIC QUALIFICATIONS

• Applicant must have a bachelors degree with 0 years of experience; OR an associates degree with 4 years of experience in Document Quality Systems; OR a high school
  diploma (or equivalent) and 6 years of relevant experience in Document Quality Systems

• Demonstrated experience with documentation systems such as PDOCs ABR RDOCS and SAP.

• Prior experience in batch record creation management and auditing is preferred.

SKILLS KNOWLEDGE & ATTRIBUTES

• Strong understanding of GMP regulations quality systems and documentation processes.

• Proficiency in managing complex documentation systems and databases (e.g. RDOCS SAP PDOCs or equivalent).

• Proficiency in Microsoft Office (Word Excel PowerPoint)

• Excellent attention to detail with the ability to identify and resolve discrepancies in documentation.

• Strong analytical and problemsolving skills to manage risk assessments holds and specification implementation.

• Ability to prioritize tasks effectively to meet production schedules and deadlines.

• Strong organizational skills with the ability to manage multiple tasks and systems simultaneously.

• Effective communication and collaboration skills to work crossfunctionally with Engineering Materials Management and other departments.

• Selfmotivated with the ability to work independently and as part of a team.

• Commitment to maintaining compliance and continuous improvement in all aspects of the role.

PREFERRED QUALIFICATIONS

• Prior experience in batch record creation management and auditing is preferred.

• Certification in GMP compliance Quality Assurance or Lean Six Sigma is a plus.

PHYSICAL/MENTAL REQUIREMENTS

• Occasionally lift a computer system and/or instrument up to 50 pounds.

• Use a computer terminal for up to 8 hours per shift work around moving equipment.

• Stand for up to 8 hours sit for up to 8 hours walking climbing stairs responding to visual warning indicators respond to audible warning indicators respond to color or special visual indicators wear specialized protective.

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Primary work schedule is Day shift Monday Friday but evenings weekends and holidays will be required as needed to support manufacturing processes at the Rocky Mount site.

• Must be able to wear proper gowning and PPE in laboratory and manufacturing areas as required to meet GMP and/or OSHA requirements.

• Minimal travel may be required.

Work Location Assignment:On Premise

OTHER JOB DETAILS

Last Date to Apply for Job: May 29th 2025

The annual base salary for this position ranges from $58500.00 to $97500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control