QC Scientist Method Transfer and Validation

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.

You will work on-site at the Pfizer Sanford North Carolina facility and will be a member of Pfizers Quality Control Portfolio Management team to support multiple quality programs. The colleague will be able to analyze chemical or biological or microbiological products. You should be able to perform the analytical or chemical or microbial and sterility testing in the GMP laboratory setting and should be able to collaborate efficiently with the external teams. Additionally the candidate should be able to document all the data to in accordance with cGMP and data integrity principles.

You should be able to review the validation data as a second analyst reviewer. Ensures that quality control procedures adequately evaluate an organizations products. Determines if current methods and techniques result in meeting reliability standards or require modification. (More concerned with standards methods and procedures than with testing devices and equipment used to check products). Devises testing plans methods and equipment to assure reliability of product in conjunction with product design and specifications. (More concerned with tests and quality control checks during and after product preparation.) Tests and inspects products to determine compliance with specifications. Include on- and off-line inspection. Performs laboratory tests on finished products raw materials and in-process material in support of the companys quality control program. Prepares reports and/or exercises administrative control in support of the companys quality control program.

Accountable for activities involved in the evaluation review and approval of the validation master plan validation protocols and reports and typically includes developing and evaluating quality process and system standards to ensure compliance with company standards and governmental regulatory requirements investigating/troubleshooting validation problems for equipment and/or performance processes conducting statistical analyses of testing results and process anomalies and writing reviewing approving and/or implementing documentation for new and current validation procedures and technical reports related to equipment products and/or processes.

What You Will Achieve

• Have comprehensive and specialized knowledge and skills in procedures techniques tools materials and/or equipment needed for position

• Have a comprehensive understanding of technical skills and operational knowledge

• Contribute to the completion of project/work group/department tasks

• Act as a lead coordinating the work of others but is not a supervisor (SME)

• Develop or adapts new processes and procedures for work area to improve performance and increase efficiency consciously balancing the risk and reward trade-off

• Non-standard work is periodically reviewed with a focus on soundness of technical judgment.

• May be responsible for reviewing the work of others within the work group

• Have deep knowledge of varied aspects or a specialized aspect of a discipline

• Be recognized as a technical expert with growing scientific contributions

• May use or develop novel processes or hypotheses;apply ingenuity; new ideas and knowledge are used frequently

• Make decisions that require choosing or developing new options to solve moderately complex problems

• Use own scientific judgment to apply and adapt standard methods and techniques with increased independence by applying prior work experience

• Work independently on assignments using knowledge and work experience

• Independently plan and execute laboratory experiments.

• Collaborate with trainers colleagues and subject matter experts to perform the assays in the laboratories including the use of computational predictive tools modeling software and data visualization tools as necessary.

• Assist teams in completing the assays required for the validation and transfer of methods.

• Engage with the method development team and participate in both in-process and final product sample analyses.

• Authorrelevant sections of technical reports to support interdepartmental technology and method validation and transfer processes.

• Prepare technical reports critically review data as second analyst for the validations and evaluate new instrumentation and analytical techniques as required.

• Independently analyze experimental data and provide conclusive insights.

• Mentor associate and senior and associate scientists and offer technical guidance when required.

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelors degree with at least 2 years of experience; OR a Masters degree with 0 years of experience; OR an Associates degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience
• Demonstrated technical knowledge of aseptic processing and sanitization.
• Basic computer skills including data entry with a high level of attention to detail.
• Extensive hands-on experience and strong background in molecular biology assays like slot blot Endotoxin Elisa CE-SDS icIEF.

Bonus Points If You Have (Preferred Requirements)

• Experience with troubleshooting assays and improving method performance.

• Strong technical writing and presentation skills.

• Experience with method validation and method transfer skills to manufacturing site.

• Experience with bio-process downstream development.

Physical/Mental Requirements

• Proven track record of independently accomplishing complex analytical method development and validation

• Excellent written and verbal communication skills

• Strong interpersonal abilities.

• Resource is expected to be self-motivated and driven and able to manage day to day work activities with minimum direction.

• Should have a positive and teamwork mindset.

• Should be an analytical thinker and use their skills to troubleshoot the daily challenges faced at the workbenches in data reviewing and documentation.

Non-Standard Work Schedule Travel or Environment Requirements

• This role is standard day Monday through Fridaywork shift. Occasional weekend/evening support may be required to support continuous improvement activities.

Other Job Details:

• Last day to Apply: June 11th 2025
• Eligible for Relocation Assistance: No
• Work Location Assignment:Hybrid

The annual base salary for this position ranges from $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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.

Quality Assurance and Control