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

ROLE SUMMARY

This posting is for QO Specialist inthe 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.  Attention to detail and the ability to prioritize multiple priorities is required.  The successful candidate will provide guidance and support to technicians and contractors in the stability area, providing support on a daily basis.  This position will also represent the unit on cross functional project teams. Cross-training to the retains area will also be a responsibility of this role, as will rotational on call requirements.  This role requires knowledge of the stability discipline to apply the skills as a technical resource and in recommendations for improvements.  The successful candidate will be able to take appropriate risks to advance moderately complex concepts across a work team.  In this role, the successful candidate will need to exercise their own judgment, leveraging knowledge and experience with the ability to work independently on assigned work.

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.

• Perform investigations (QARs / ERs) and resolution of items outside of the routine workload.

• With minimal support, lead complex projects, including lightspeed projects, that have impact throughout the network.  This requires networking with other sites and functional groups to ensure that stability requirements are met.

• Process revisions to documents using local change control systems (Stability protocols, SOPs, Quality Memos, etc.).

• Interact with individuals at a variety of levels in the following areas to ensure the stability program maintains a high level of compliance: Operations, Quality Operations Laboratories, Quality Assurance, Complaints, SLS Stability.

• Meet performance metrics for supported programs – 100% on time stability pulls, all QTS records approved within due dates.

• Identify and implement solutions to issues including effective CAPAs with site-wide impact

• Ability to make and understand the impact of decisions that may have impact outside business unit (site-wide / network-wide)

• Identify problems or gaps, drive to fix (brings solution) and coach other colleagues on solutions

• Provide regulatory/compliance knowledge to cross site efforts.

• With minimal direction, supports site-wide continuous improvement projects

Qualifications

Must Haves

• Applicant must have six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.  

• Knowledge and use of quality systems (e.g. LIMS, SAP, QTS) is required

Nice to Haves

• Familiarity with Stability programs

• Excellent organizational skills and demonstrated ability to meet changing deadlines and deliver results on time

• Excellent communication skills to support all levels of customers and maintain effective customer relationships

• Demonstrated agility/performance in a changing environment and have a willingness to be active in continuous improvement initiatives

• Demonstrated ability to work both independently and in a team environment

• Demonstrated commitment to values based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core Competencies

• Ability to comprehend and apply information from guidance documents (e.g. PQS, CFR) to functional processes

PHYSICAL/MENTAL REQUIREMENTS

Ability to lift up to 35 pounds

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Generally First shift, 8:00-4:30. Extended work hours or weekend work may be required.  Rotational call is required. 

Work Location Assignment: Flexible

Last Day To Apply: April 12th, 2023.

Relocation: NO

Referral Bonus: Yes

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