Senior Quality Assurance Associate

1st 2 Months Training Schedule: 1st shift 8:00 AM - 5:00 PM

After Training Schedule: 3rd shift 11:00 PM - 7:30 AM (includes 30 minute lunch)

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 our dedicated and highly effective Manufacturing Quality Assurance team. You will evaluate and review manufacturing related activities in support of clinical and commercial batch production. Your expertise will help in identifying deviations from established standards, in the manufacturing of clinical and commercial batches. In the relevant cases you will approve change control activities to ensure compliance to procedures/GMPs.

As a Quality Assurance 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 explaining difficult issues and establishing consensus between teams.

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

Responsibilities:

• 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.
• Contribute to Quality Assurance activities by performing manufacturing floor support, batch record review and other duties as assigned.
• Independently assess production activities to determine potential Quality and Operational impact.
• Suggest improvements and conduct continuous improvement activities.
• Document deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
• Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
• Provide Quality Review and oversight of site cGXP documentation related to the Sanford Production Operations and site activities to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.

Qualifications:

• Minimum HS diploma with 8 years' experience OR an Associate's degree with 6 years experience OR a Bachelor's degree with 3 years' experience or a Master's degree with 1 years' experience
• Previous experience in QA/QC, Manufacturing and/or Engineering strongly preferred
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Proactive approach and strong critical thinking skills.
• Strong collaboration, relationship management and interpersonal skills.
• Must be able to work in a team environment within own team and interdepartmental teams.
• Excellent written and verbal communication.
• 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 regardless of circumstances and stress induced pressure.
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as SAP, Quality Tracking System (Trackwise), Veeva Vault, LIMS.

Rate/Hours:

• $40 - $50 per hour
• Onsite in Sanford, NC

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits, and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued, and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.