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.

ROLE SUMMARY

This posting is for a Sr Specialist QO in the Analytical Services group, supporting the Site Stability program. This position is responsible for ensuring the Stability program remains in compliance with both internal and external regulatory requirements through maintenance of area standard operating procedures and training documents, understanding of requirements for handling and storage of controlled substances, and equipment monitoring and periodic reviews. The successful candidate will provide guidance and support to technicians in the area, represent the unit on cross functional project teams, and function as a subject matter expert during audits.

ROLE RESPONSIBILITIES

* Work with operations schedulers to order stability lots required by SLS stability protocols, provide lot information obtained from SAP, LIMS, and various other sources to SLS stability group to ensure appropriate study creation in LIMS, and ensure samples are transferred to the appropriate storage conditions according to a defined schedule. Ensure samples are pulled and delivered to labs for testing at appropriate intervals.

* Assist team members and customers in investigation and resolution of items outside of the routine workload.

* Assist customers with special requests or needs.

* Lead or contribute to special projects.

* Process revisions to documents using local change control systems.

* Participate in system development and design.

* Interact with individuals at a variety of levels in the following areas: Operations, Quality Operations Laboratories, Quality Assurance, Complaints, SLS Stability.

* Meet performance metrics for supported programs.

Qualifications

Must-Have

* Bachelor's Degree (science or related field is preferred)
* 3+ years' experience
* Experience in Quality administered systems
* Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
* Proactive approach and strong critical thinking skills
* Must be able to work in a team environment within own team and interdepartmental teams
* Excellent communication and interpersonal skills

Nice-to-Have

* Familiarity with Stability Programs
* Knowledge and use of quality systems (e.g. LIMS, SAP, QTS) is required
* Ability to comprehend and apply information from guidance documents (e.g. PQS, CFR) to functional processes
* Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
* Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

PHYSICAL/MENTAL REQUIREMENTS

Ability to lift up to 35 pounds

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Off-hours/on-call support is required on a rotational basis.

OTHER INFORMATION

* Last Date to Apply for Job: 3/11/21
* Eligible for Employee Referral Bonus

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 E-Verify employer.

Quality Assurance and Control

LI-PFE