QC Scientist III

Use Your Power for Purpose

At Pfizer, every day is an opportunity to make a difference in patients' lives. Your contributions will directly impact patient care, as you work within a flexible, innovative, and customer-oriented culture rooted in science and risk-based compliance. By joining our team, you will help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

Role Summary

The qualified candidate will provide analytical testing support for in-process / drug substance for new and existing products in a cGMP quality control analytical (QCA) laboratory.  You will be responsible for analyzing chemical, biological and/or microbiological products to support our quality programs. Supported activities include analytical technology transfer, analytical method optimization, qualifications, validations, comparability, and evaluation/implementation of new technologies. Troubleshooting activities in support of QC labs and manufacturing are also included.

What You Will Achieve

In this role, you will:

• Validate analytical test methods, author test method documents, support specification and list of test method development and ensure effective method transfer from the technical support group to the release laboratory by training analysts.  

• Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

• Provide technical support for new analytical methods, troubleshooting methods, investigations and method improvements.

• Analyze and interpret results, make decisions regarding accuracy, completeness and compliance.

• Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

• Support sustainability of Integrated Manufacturing Excellence (IMEx) elements within the group.

• Identify technical issues, method performance issues, instrument malfunctions and methodology problems and participate in necessary investigations aimed at mitigation.

• Maintain all related data and records in compliance with cGMPs and quality procedures

• Write and review technical documents such as validation protocols and reports in support of product validations/qualifications/comparability and investigations and change controls.

• Meet all timelines and deliverables in support of Andover plan of record and product life cycle.

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

• Knowledge and practical application of relevant analytical techniques

• Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.

• Experience in method troubleshooting and laboratory investigations

• Experience with cGMPs and regulatory guidance

• Experience with HPLC, CE, gel, spectroscopy

• Possess strong problem-solving skills

• Demonstrated planning and prioritization skills with a focus on team success in meeting defined timelines.

• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)

• Knowledge of Empower Software

• Ability to manage projects with minimal supervision

• Excellent oral and written communication skills

Bonus Points If You Have (Preferred Requirements)

• Protein experience

• Strong troubleshooting skills

• Working understanding of IMEx principles

PHYSICAL/MENTAL REQUIREMENTS

• Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.). 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Position is first shift Monday through Friday on-site.  Some off hour (night/weekend/holiday) support may be required to support staff and operations.

OTHER JOB DETAILS

Last Date to Apply for Job: Feb 23, 2025.

Referral Bonus Eligibility: YES

Eligible for Relocation Package: NO

Work Location Assignment: On