Lab Compliance Analyst

at  Pfizer

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
Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
As laboratory compliance analyst, 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

• Prepare equipment and reagents to be used in testing
• Perform analytical method validation/verification, study protocol, cleaning method validation and equipment/instrument qualification in accordance to approved protocol and record the results in timely manner
• Assist QC Lab Supervisor and QC Manager in Laboratory Investigation in case out of acceptance criteria/specification
• Participating in Qualification and Calibration Program
• Ensure all reagents and reference standards are valid and stored according to requirement
• Perform verification or calibration of instruments/equipment according to approved procedures and schedules
• Support QC Lab Supervisor to manage and maintain the implementation of compendia compliance in QC Area
• Support to maintain QC Laboratory documentation (including registration dossier related to laboratory document) in QC Chemical Lab
• Perform testing product/material as backup personnel of QC raw material or finished good
• Prepare annual product review data from QC Chemical Laboratory
• Develop or revise SOP or Form in Laboratory, if necessary
• Maintain Lab Area and facilities in a clean, orderly and operational state

Qualifications

Must-Have

• High School Diploma or GED
• 1+ years’ experience
• Certification in assigned area, if applicable
• Successful hands-on analytical testing experience in a Good Manufacturing Practices {also cGMP} environment
• Technical Skills- Knowledge of laboratory equipment, testing and technique
• Basic math skills and computer skills, such as data entry, along with a high level of attention to detail
• Strong organizational skills and ability to multi-task across projects and activities
• Must be self-motivated and work with minimal direction
• Ability to read, communicate understanding and follow written procedures

Nice-to-Have

• Bachelor’s Degree
• Experienced in analytical method development
• Familiar with monograph and compendia requirement
• Demonstrate proficiency in computerized systems, such as Laboratory Information Management System

Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

Please refer the Job description for details