QS Documentation Systems Administrator
QS Documentation Systems Administrator
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$ 80300 - 133900
1 Vacancy
Job Description
ROLE SUMMARY
The QS Document Systems Administrator leads and advances documentation systems like rDOCs QDOCs SDS/electronic forms and PDOCs at the Rocky Mount site to support batch records and SOPs. They ensure successful project execution by providing technical expertise and managing budgets timelines and compliance.
The Administrator works with crossfunctional stakeholders to plan implement and evaluate documentation programs. They oversee critical systems transition paper records to electronic formats and manage Pfizer Logbook (PLOG) and Central Index of Company Records (CICR) projects. They are also responsible for any system updates needed to maintain functionality and efficiency. They serve as a subject matter expert for documentation change impact assessments ensuring compliance with Pfizer Quality Standards and regulations.
The role requires strong leadership organizational and communication skills to manage complex projects and uphold the sites quality and innovation standards.
ROLE RESPONSIBILITIES
Responsible for overseeing and maintaining documentation systems including rDOCs and PDOCs to support batch records and SOPs while ensuring adherence to GMP and regulatory requirements.
This role provides project management support to execute documentation projects within established budgets and timelines.
Responsible to create monitor and track Pfizer Quality Standards (PQS) CAS reports to inform site Subject Matter Experts (SMEs) of changes.
Responsible for scheduling meetings initiating CAPAs and ensuring timely completion of PQS documentationrelated tasks.
Responsible for writing deviation events for documentation issues performing comprehensive impact assessments and completing CAPAs to address any deficiencies or process improvements within the department.
The administrator also manages the Pfizer Logbook (PLOG) project overseeing the creation and implementation of eLogbooks providing system access conducting departmental meetings and ensuring accurate tracking of project milestones. They collaborate with thirdparty Program Directors to assess plan and execute action items related to the Central Index of Company Records (CICR) supporting record management functions and transitioning logbooks to the PLOG system.
This role serves as the point of contact and Subject Matter Expert (SME) for Documentation Management systems impact assessments ensuring that all changes are thoroughly evaluated and aligned with regulatory standards and internal policies.
Create and disseminate work plans procedures and progress reports documenting key decisions and collaborating with project teams to ensure alignment with site goals.
Responsible for ensuring the timely resolution of deviations effective CAPA implementation and the development of strategies to prevent recurrence. They maintain compliance with GMP regulations by managing sensitive and confidential information with professionalism and tact while supporting regulatory inspections and internal audits.
Responsible to ensure operational excellence regulatory compliance and continuous improvement within the department Bb providing leadership in documentation system management deviation resolution and CAPA completion the QS Document Systems Administrator.
BASIC QUALIFICATIONS
Applicant must have a bachelors degree with at least 2 years of experience; OR a masters degree with 0 years of experience; OR an associates degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
The ideal candidate will have the ability to learn quickly and navigate electronic systems to facilitate the routine operation and maintenance of site documentation systems and related processes.
This role demands a team player with strong interpersonal organizational and communication skills. Candidates must be selfmotivated engaged and capable of performing moderately complex tasks independently. Prior experience working with GMP documentation and an understanding of GMP regulations quality systems and documentation processes are essential. Strong communication skills both written and verbal including presentation abilities are also required.
The candidate must possess a strong understanding of GMP regulations quality systems and documentation management processes. Proficiency in managing complex documentation systems and databases (e.g. RDOCS SAP or equivalent) is required along with expertise in Microsoft Office applications (Word Excel and PowerPoint). Attention to detail is critical to identify and resolve discrepancies in documentation. Strong analytical and problemsolving skills are necessary for managing risk assessments holds and specification implementations as well as the ability to prioritize tasks to meet production schedules and deadlines.
This role requires exceptional analytical skills to monitor program benchmarks assess data and identify opportunities for process improvements.
The role requires exceptional organizational skills to manage multiple tasks and systems simultaneously. Effective communication and collaboration skills are essential for crossfunctional interactions with Engineering Materials Management and other departments. A selfmotivated approach and the ability to work both independently and as part of a team are critical attributes. The candidate must demonstrate a strong commitment to 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
Mathematical calculation and complex data analysis ability.
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 $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0% 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.
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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
