QA Gene Therapy Sr. Associate - Investigation Reviewer

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and 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 Quality Assurance department by performing Quality activities associated with Gene Therapy manufacturing operations.

You will be primarily responsible for performing the following Quality Assurance (QA) responsibilities: investigation review and approval and Corrective Action/Preventative Action (CAPA) approval. Additional responsibilities may include: batch disposition, manufacturing floor support including aseptic observations, change control approval, product and material release, complaints handling, Biological Product Deviation Reports (BPDR) issuance, Annual Product Record Reviews (APRR), and standard operating procedure and manufacturing batch record approval.

As a QA Sr. Associate, your knowledge and skills will contribute towards the goals and objectives of the team. 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, investigations, change controls, and risk assessments (facilitator and/or team member).

How You Will Achieve It

• Act as a primary point of contact for the QA organization for investigation support and review
• 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 providing aseptic observations for drug product related processes (i.e. review in-process records, observe media fills, aseptic observation, airflow visualization review etc.).
• Act as SME for department to support site audits/inspections.
• Interface with other parts of the organization such as Global Quality Operations groups and Pfizer Research and Development groups.
• Review and approve investigation and CAPA records to assure compliance with regulatory standards and regulatory filing.
• Provide manufacturing floor support that may include weekends and first, and/or third shift hours on occasion. Assess the operations executed for adherence to regulatory requirements, Quality Agreement requirements and Pfizer expectations.

QUALIFICATIONS

Must-Have

• Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• 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
• Experience in Quality platforms (e.g LIMS, QTS, eQMS, SAP, DMS)

Nice-to-Have

• 3+ years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a 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 to 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 occasional weekend support and second, and/or third shift hours 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.

Relocation support available

Work Location Assignment:Flexible

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.