Contribute to project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.
Make decisions within limited options to resolve basic problems, working under the supervisor's direction and seeking guidance from colleagues.
Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor.
Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records.
Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions.
Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.
Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating with Business Area Training Leads, Coordinators, and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and approval.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices
Strong organizational skills and the ability to manage changing deadlines
Proficiency in Microsoft Office, particularly Excel, for data evaluation
Strong written and verbal communication skills
Ability to work in a team environment and collaborate effectively with colleagues
Basic understanding of validation principles and practices
Bonus Points If You Have (Preferred Requirements)
Technical writing experience, particularly within the pharmaceutical industry
Laboratory process validation expertise
Working knowledge of equipment qualification and calibration, especially for laboratory equipment
Experience with regulatory queries and responses
Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams
Adaptability and flexibility in a dynamic work environment
Commitment to continuous learning and professional development
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Quality Assurance and Control
