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Sr QO Specialist - Data Integrity

Employer
Pfizer
Location
Rochester, Michigan
Start date
Sep 23, 2022

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Discipline
Clinical, Clinical Medicine
Required Education
High School or equivalent
Position Type
Full time
Hotbed
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Job Details

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

As a Data Integrity Specialist, you will be knowledgeable in the subject of data integrity requirements and expectations. You will support PGS policies and global regulations to ensure the integrity of GMP data generated to support manufacturing and testing processes. This role supports the objectives of the DI governance.

How You Will Achieve It
  • As a member of the Data Integrity Team, you will:

  • Support implementation of data integrity governance.
  • Support GMP data lifecycle requirements to align with data integrity governance.
  • Assists with data integrity metrics activities (gathering, tracking, and reporting, etc.).
  • Participate in routine audits, communication of weekly data integrity awareness topics, and preparation of monthly reports to the Site Leadership Team.
  • Collaborate with cross functional teams for continuous improvement of processes to facilitate “Right-First-Time” principle.
  • Facilitate risk assessments throughout the GMP data lifecycle (e.g., for new and existing GMP equipment, instrumentations, and systems).
  • Maintain knowledge and execution of policies and procedures as necessary to ensure clear directions and understanding of data integrity principles and requirements.
  • Support the change control process with respect to potential data integrity impact and ensure appropriate implementation actions are carried out to maintain compliance.
  • Participate in data integrity applicable deviation investigations.
  • Drive mitigation and remediation efforts to completion.

Qualifications

Must have

  • Applicant must have High School Diploma (or Equivalent) with 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. Degree preference in Information Technology, Chemical / Biological Science, Engineering, or a related technical field.
  • 2+ years’ experience in the Pharmaceutical Industry with related technical quality knowledge.
  • Knowledge of manufacturing equipment and data, laboratory instrumentations and data, and associated computerized systems, including TrackWise.
  • Understanding of current Good Manufacturing Practices and application of 21 CFR Part 11 and Annex 11, including Computer System Validation Lifecycle. Computer system / equipment validation experience is preferred.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
  • Multi-tasking and organizational skills required
  • Ability to work with cross-functional teams effectively
  • Excellent communication and strong team building skills.

PHYSICAL/MENTAL REQUIREMENTS

Must not be allergic to Penicillin.


Work Location Assignment:On Premise

Last Date to Apply for Job: October 7, 2022

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

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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