Senior Quality Associate

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

The Pfizer Sanford, NC site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products.This position will support the Pfizer Sanford Manufacturing Quality Assurance department by performing Quality activities associated with Gene Therapy (GTx) manufacturing operations.

You will be responsible for performing the following Quality Assurance (QA) responsibilities: batch disposition activities, manufacturing shop floor support including aseptic observations, investigation approval, change control approval, product and material release, complaints handling, , Annual Product Record Reviews (APRR), and standard operating procedure and manufacturing batch record approval. In addition, the position will be responsible for ensuring alignment with the Manufacturing Clinical and Commercial Quality Operations role.

As a GTx Quality Assurance Sr. Associate, your knowledge and skills will contribute towards the goals and objectives of the team. This includes demonstrating independent decision-making in support of manufacturing. Strong communication skills are required to facilitate explaining difficult issues and achieving consensus between teams.

The individual should be able to demonstrate the following:

• Demonstrate knowledge of and adherence to EH&S safety requirements for site
• Display knowledge in cGXP, manufacturing operations, batch disposition, and Aseptic principles and concepts
• Good foundation in general scientific practice and principles
• Excellent written and verbal communication and interpersonal skills
• Ability to organize and track status of assigned actions across multiple production areas
• Organizes and provides written and/or oral presentations of work with minimal input
• Ability to follow written procedures and learn from hands-on training
• Participates in activities/projects to support work group/project team goals
• Approve SOPs, forms, protocols, change controls, and risk assessments (facilitator and/or team member).

How You Will Achieve It

• Act as a point of contact for Quality Assurance to support production
• Demonstrate good decision-making skills
• Demonstrate strong knowledge/understanding of the principles and concepts of aseptic technique and manufacturing operations.
• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Suggest improvements and conduct continuous improvement activities.
• Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
• Provide Quality review and oversight of site cGxP documentation related to the operation of a Gene Therapy manufacturing facility to ensure compliance with global regulatory agencies and Pfizer Quality Standards.
• Provide Quality support on the shop floor by maintaining presence during manufacturing operations, providing aseptic observations for drug product related processes (i.e. review in-process records, observe media fills, aseptic observation, airflow visualization review etc.), and conducting visual inspection for Drug Product operations.
• Acts as SME for department to support site audits/inspections.
• Interfaces with other parts of the organization such as Global Quality Operations groups and Pfizer Research and Development groups.
• Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
• Provide manufacturing floor support that may include occasional weekends and second and/or third shift hours. Assess the operations executed for adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectations.

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate’s degree with 6 years of experience OR a Bachelor’s with at least 3 years of experience OR Master’s with more than 1 year of experience.
• Manufacturing, Quality or Engineering experience in the biotech or pharmaceutical industry
• Knowledge of current Good Manufacturing Practices and applicable GxP regulations and standards
• Experience in Quality platforms (e.g LIMS, QTS, eQMS, SAP, DMS)
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
• Excellent communication, decision-making and interpersonal skills
• Good working knowledge of Microsoft Excel and Word

Nice-to-Have

• Degree in Science/related field
• Previous experience with a startup facility and developing Quality Operations processes is beneficial.
• Experience with Drug Substance and Drug Product clinical/commercial manufacturing preferred.
• Preferred experience with aseptic practices, investigations, and disposition activities.
• Willing to lead by example and be a collaborative and active listener.
• Effectively manages stressful situations, able to focus on tasks

Physical / Mental requirements

• Requires working on shop floor and in an office setting.
• Computer usage would be typical.
• Ability to stand for 2-3 hours at a time, sit for 2 to 3 hours at a time, aseptically gown into manufacturing areas, and walk long distances.

Non-Standard work schedule, travel or environment requirements

• Work schedule is primarily first shift during weekdays but may include weekends and second and/or third shift hours on occasion to support manufacturing operations activities.
• Ability to adhere to safe work practices and procedures such as aseptic gowning.
• Limited travel for the position; no more than 5% traveling.
• Job requires majority on-site presence.

Other job details

• Last day to appy: January 30th, 2024
• Employee Referral Bonus eligible
• Relocation support available

Work Location Assignment:On Premise

The annual base salary for this position ranges from $78,000.00 to $126,300.00. 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 tendersglobal.net (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.

Quality Assurance and Control