Associate, Records Management

Pfizer Inc.

Sanford, NC

Job posting number: #7135236 (Ref:pf-4881029)

Posted: March 21, 2023

Application Deadline: Open Until Filled

Job Description

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.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Prepare master batch records (MBRs) for issuance to the manufacturing team to support plan of record for the site. Tasks include but not limited to:
    • Printing of records from DMS (Document Management System)
    • Assembly ancillary documents to be used with the PBRs
    • Ensure records are complete and perform 2nd review prior to issuance.
  • Manage Document workflows for creation of new files within the Pfizer global electronic document management system for all files created to be stored on site until the file is sent to Pfizer Records Service Center for offsite storage according to current Record Retention Schedule.
  • Provide support to regulatory inspections and audits through the preparation, maintenance and delivery of records as requested.
  • Interact with multiple colleagues and departments throughout the Sanford site to determine best format for accurate record keeping and provide records and information in a timely and professional manner.
  • Perform control print reconciliations, second reviews of batch and compound records.
  • Provide Site level support to Investigations, Change Control, QC Laboratories and Manufacturing Areas for Batch Issuance, Records Management and Label Management Issue Production Labels to Manufacturing
  • Perform document review, revision and approval for Site SOPs, Job-Aids, Forms, Master Production Labels and other Controlled Documents
  • Able to accurately execute multiple projects at the same time and provide effective communication to colleagues and area management on current practices and new initiatives.
  • Prioritize project completion to meet target timelines and develop individual work plan to achieve targeted goals.
  • Identify, suggest, and conduct continuous improvement activities.
  • Assesses existing situations and suggests improvements in the Records Management process.
  • Interfaces with other parts of the organization such as Operations, Quality management, and other Document Control supporting functions on site.

Qualifications

Must-Have

  • Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.  
  • Experience in a document-related or supporting function is required, preferably in a Biopharmaceutical or other regulated environment.
  • Experience working with GMP records.
  • Experience in pharmaceutical industry
  • Experience in Quality administered systems
  • Sound knowledge of current Good Manufacturing Practices {part of GxP}
  • Ability to work in a team environment within own team and interdepartmental teams
  • Effective written and oral communication skills

Nice-to-Have

  • Experience at a manufacturing site
  • Experience of writing and managing deviations
  • Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management

PHYSICAL/MENTAL REQUIREMENTS

  • 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.
  • Attention to detail
  • Strong organizational and communication skills
  • Team based collaborative problem solving

Last Date to Apply for Job: April 3, 2023
Eligible for Relocation Package: No

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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



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.


Apply Now

Please mention to the employer that you saw this ad on AcademicWomen.com