Senior Data Integrity Analyst

Employer
Pfizer
Location
Rocky Mount, North Carolina
Posted
Jul 30, 2021
Ref
4816099
Required Education
Bachelors Degree
Position Type
Full time
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

In your role, you have the all-important task of ensuring that quality control procedures adequately evaluate our organization's products. You will be relied on to determine if our current methods and techniques result in meeting the prescribed standards, methods and procedures.

You will analyze and design inspection and testing process, develop new analytical methods and techniques to support our quality programs. You will provide statistical analysis, centralized investigation support, technology implementation, and establish requirements for the transfer of methodology from R&D. You will ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It
  • The Senior Data Integrity Analyst performs system analysis and interventions to assure that the data generation and documentation systems are maintained in a validated state of the Rocky Mount Laboratory computerized systems. 

  • These systems include, but are not limited to, Lab Information Management System (LIMS), NuGenesis, Empower and other lab applications utilized for instrument and data management to assure that data generated is integral and complete throughout the data retention lifecycle in conjunction with BTAMS.

  • This position is also integral in performing assessments of electronic and manual data generation processes at the Ricky Mount site to assure that data integrity is maintained throughout the data retention lifecycle.

  • This position provides input to and implements enhancements to the laboratory systems that generate and maintain data in order to maintain data integrity.  Responsibilities include assessing changes to user and testing specifications and regulatory requirements per 21 CFR Part 11, PIC/s Annex 11, GAMP5, and current regulatory Data integrity guidance documents, determining the impact of software updates and user requested changes with regard to product and process  data quality, and implementing appropriate measures / controls within the laboratory systems to ensure compliance. 

  • The roles are also responsible for performing system administration, application support, software / hardware validation support, incident management, technical expertise, and production support to quality labs, lot release/supply chain, and manufacturing. 

  • Understanding of database structure and system security is necessary for this position.

  • System support may include system configuration, designing and building application reports or reporting tools, maintaining or creating master data for new or existing products, software utilities, maintaining system documentation, and providing ad hoc support to other departments as needed. 

  • This position is expected to provide leadership to support system evolution and continuous improvement for all lab system and to support laboratory informatics and data integrity efforts applicable to data generated from these systems and processes.

Qualifications

Must-Have
  • Bachelor’s degree in life sciences, computer science, or engineering required.

  • Minimum of 4 years working in a GMP environment (preferably in a pharmaceutical company).

  • 5 years related laboratory application management experience: configuration, validation, implementation, and system administration. 

  • 5 years’ experience in a GMP environment with working knowledge of laboratory specification and test documentation in electronic systems.

  • 2 to 4 years in computer system validation and analytical instrumentation testing.

Nice-to-Have
  • Master's degree

  • Experience in project management and business analysis

  • Experience in Empower, NuGenesis, Chromeleon, or WinKQCL is desired. 

  • Environmental Monitoring or program design experience desired.

PHYSICAL/MENTAL REQUIREMENTS

  • Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 5 pounds per activity 4 times per shift, work around moving equipment, work with biological materials.

  • 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

  • Mathematical and scientific reasoning ability

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • May be required to work non-standard hours to support laboratory systems at the Rocky Mount site.

OTHER JOB DETAILS:

  • Last day to apply: 8/9/2021

  • Employee Referral Bonus eligible

  • Relocation support available

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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

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