Sr Associate Quality Systems

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 Systems team. You will be responsible for activities involved in System Administration of documentation systems overseen by Quality Records Management. You will also be relied on to support document processing and/or records retention activities as needed, performance metrics and Quality Systems goals and objectives.

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 critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

• Review and interpret metrics, provide assistance and input to determine action plans needed to maintain or improve the state of compliance in applications overseen by Quality Records Management

• Perform system administration duties for quality systems overseen by Quality Records Management, including being a subject matter expert for system functionality and providing support to end users

• Participate on and contribute to group engagement teams to evaluate and recommend improvements to quality systems overseen by Quality Records Management

• Assist with the creation of clear and concise change records to support changes to related to quality systems overseen by Quality Records Management

• Support Records Retention activities as needed

• Support document processing activities as needed

Qualifications

Must-Have

• Applicant must have eight years of relevant experience; OR an Associate’s degree with at least 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.  

• Previous experience working with electronic documentation systems

• Strong interpersonal skills

• Excellent organizational skills, ability to handle changing deadlines and responsibilities.

• Strong written and verbal communication skills

• Strong computer knowledge (MS Office Suite)

Nice-to-Have

• Master's degree

• Demonstrated ability to learn and master new applications software

• Experience in writing/executing change controls

• Experience with computer validation

• Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry

PHYSICAL/MENTAL REQUIREMENTS

Sitting, standing, walking, potentially some lifting

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

None

Work Location Assignment: Hybrid Position 2-3 days per week on Premises

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