QC Quality Support Engineer

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

In this role, you will:

Perform validation testing, system administrator management, laboratory support and laboratory troubleshooting on laboratory instruments and computer systems.

• Plan, develop, and execute Installation Qualifications (IQ), Operation Qualifications (OQ), Performance Qualifications (PQ).

• Develop and execute validation and verification plans in line with system requirements.

• Assist with validation lifecycle activities (URS, ERES, IOPQ, DRA, CS, FS, & TM)

• Develop and Perform Validation Protocols based on system requirements.

• Perform System Administrator management functions on all Laboratory Systems.

• Manage and monitor local servers, workstations, and networks supporting laboratory operations.

• Create Periodic Review Reports, Audit Trail Review Reports, User Recertification Reports, and Workstation Monitoring Reports.

• Troubleshoot computer hardware and software error messages on laboratory systems.

• Support laboratory metrics and drive continuous improvement of cGMP in laboratory.

• Maintain data integrity principles in everyday laboratory operations.

• Assist with additional activities as position requires.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards

• Strong critical thinking skills

• Proactive approach to problem-solving

• A team player with strong interpersonal, organizational, and communications skills. Self-motivated, engaged and able to perform moderately complex tasks independently.

• Good working knowledge of Microsoft Excel and Word

Bonus Points If You Have (Preferred Requirements)

• Biopharma/pharma industry experience that includes a broad understanding of Biopharmaceutical Sciences processes and Quality Systems.

• Experienced practitioner of Data Integrity principles.

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

• Knowledge of pharmaceutical QC quality systems

  

PHYSICAL/MENTAL REQUIREMENTS

This position will spend significant time in a laboratory environment and must be able to wear all required PPE.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• May require support for site as needed beyond core business hours.

• No travel required

Work Location Assignment: On Premise

The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

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 h