QC Quality Support Engineer

Pfizer • Pearl River, NY • 8h ago

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 health care provider's 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. This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control

Pfizer

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