We Hire America - Veterans Jobs

Mobile We Hire America Veterans Logo
WeHireAmerica-Veterans.jobs is a service of HR Policy Foundation and DirectEmployers Association. These two non-profit organizations are providing this free resource to help educators, policy makers and job seekers understand the great employment opportunities available here in the U.S. at some of America's biggest and best companies.

Job Information

Pfizer Gene Therapy Downstream Quality Operations Sr. Associate in Sanford, North Carolina

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

You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • 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.

  • Review/approve Quality related investigations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.

  • Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.

  • 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 biologics manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.

  • Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.

  • Review and approve complaints.

  • Author annual product quality review reports.

  • Review and approve annual product quality review reports.

  • Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.

  • Provide Quality support on the shop floor (i.e. review in-process records, observe media fills, etc.).

Qualifications

Must-Have

  • Bachelors degree and 3+ years of quality, manufacturing or engineering experience in the biotech or pharmaceutical industry

  • Masters degree and 1-2 years of quality, manufacturing or engineering experience in the biotech or pharmaceutical industry

  • Experience in Quality administered systems

  • 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 and interpersonal skills

  • Good working knowledge of Microsoft Excel and Word

Nice-to-Have

  • Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

  • Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

  • Previous experience with a startup facility and developing Quality Operations processes

PHYSICAL/MENTAL REQUIREMENTS

Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm.

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.

Limited travel for the position; no more than 5% traveling.

It will be necessary to work in areas that require aseptic gowning.

Other Job Details

  • Last Date to Apply for Job: October 27, 2021

  • Eligible for Relocation Package: YES

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.

Quality Assurance and Control

#LI-PFE

DirectEmployers