Quality Assurance Data Analyst
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Job Description
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
What You Will Achieve
In this role, you will:
Provide oversight during execution of media fills, airflow visualization studies and other manufacturing activities.
Perform necessary assessments of aseptic operation and update necessary documents.
Accumulate key metrics for presentation to Management team, including gowning and aseptic technique observation.
Author/revise the site Microbial Contamination Control Strategy plans as required.
Author EM Quarterly and Annual Trend Reports
Author ISO Data reports in support of facility ISO recertification.
Compile, extrapolate, analyze and communicate data patterns within LIMS/MODA data. Provide Business Unit leadership data for trend reports, weekly excursion reports, quarterly SQRT meetings, audit requests and investigations.
Track, close, and implement CAPAs
Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.
Liaise with manufacturing, maintenance and aseptic trainers to appropriately schedule activities impacting the manufacturing areas.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree, discipline in a technical field such as engineering preferred, with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
Requires strong oral, written, communication, presentation and interpersonal skills. The position is self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint.
Requires thorough knowledge of GMP’s and aseptic processing. Must have the ability to handle multiple projects in a dynamic environment.
Must have the ability to handle multiple projects in a dynamic environment
Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint
Pharmaceutical operations experience and/or knowledge
Working knowledge of FDA regulations
Knowledge of various quality tools
Bonus Points If You Have (Preferred Requirements)
Experience at a manufacturing site.
Experience in aseptic manufacturing.
Managing and writing deviations
Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
Strong problem-solving skills
Ability to work independently and as part of a team
Excellent time management and multitasking abilities
PHYSICAL/MENTAL REQUIREMENTS
Must be able to function under a stressful situation while being able to remain focused on the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis. Must be comfortable working in an Open Office setting.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to work on weekends, off shifts, and holidays as business demands.
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.