Lab Compliance Analyst
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.
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 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 Compliance Supervisor to manage and maintain the implementation of compendia compliance in QC Area
Support to maintain QC Laboratory documentation in QC Chemical Lab
Perform testing product/material as backup personnel of QC operation
Manage stability study sample and stability chamber
Prepare annual product review data from QC Chemical and Micro 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#LI-PFEPfizer 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.