QA Specialist III

Description

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

• 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.
• Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.
• Investigate, document Quality Assurance related 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 {part of GxP} practices.
• Provide Quality Review and oversight of site cGXP documentation related to the operation of Drug Substance manufacturing facility 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 approval of validation documents Process, cleaning & method validation.
• Develop annual product quality review plan.
• Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor's degree with 2+ years of experience; OR a Master's degree with 0+ years of experience; OR an Associate's degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience

• Experience in Quality administered systems

• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards

• Excellent communication and interpersonal skills

• Good working knowledge of Microsoft Excel and Word

Bonus Points If You Have (Preferred Requirements):

• Master's degree and relevant pharmaceutical experience
• 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

  
Physical/Mental Requirements:

• Position requirements are typical for an office-lab work environment with some shop floor exposure.
• Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams

Non-Standard Work Schedule, Travel, or Environment Requirements :

• Position is first shift Monday- Friday (8 Hours per day). Some occasional off support may be required to support staff and operations.

Other Job Details:

• Last day to Apply: May 2nd, 2025
• Eligible for Relocation Assistance: No
• Work Location Assignment: Hybrid

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