QC Stability Operations Specialist

Requirements

• Applicant must have a bachelor's degree 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
• Experience with quality systems such as investigations, CAPA, Change Control, and Commitments
• Proficient with Trackwise and Vault
• QC experience in GMP environment
• LIMS experience (LabWare LIMS a plus)
• Bachelor's degree in engineering, science, or related field
• PHYSICAL/MENTAL REQUIREMENTS
• Job will include standing, walking, and sitting.
• Manufacturing suite and lab gowning/PPE
• Handle multiple projects with competing priorities
• Other Job Details:
• Work Location Assignment: On Premise
• Last day to apply: June 23
• Relocation assistance may be available based on business needs and/or eligibility.
• Candidates must be authorized to be employed in the U.S. by any employer.
• U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
• Sunshine Act
• EEO & Employment Eligibility

Benefits

Additional Information

Why Patients Need You The QC Stability Operations Specialist will join and support a diverse Quality Control Laboratory Operations Support (QCLOS) team consisting of Quality Control Stability Operations, Quality Control Sample Management (QCSM), and Quality Control Sampling Operations (QCSO). The role is responsible for intake and enrollment of stability study material, scheduled pulls and aliquoting of study timepoints, coordinating with internal and external team members to ensure that systems are in place to execute co-testing agreements between external Pfizer sites, contract manufacturers, and the Andover Quality Control team. This position will work closely with Quality Sample Management (QSM) and Quality Control Sampling Operations (QCSO) to ensure that there is a robust, end-to-end process for internal manufacturing support and external testing support throughout the sample lifecycle. How You Will Achieve It Enroll product into the Quality Stability program and maintain inventory throughout the duration of the study. Own quality system records (deviations, CAPAs, change controls) as needed to support department initiatives and commitments. Create or revise procedures in support of continuous process improvement. Perform Impact Assessments for changes affecting Quality Control Laboratory Operations Support teams. Submit Master Data Requests (MDR) to support changes required in LIMS. Contribute to and/or own Quality Risk Assessments and Training Guides. Collaborate with internal and external stakeholders to streamline testing timelines and cross-functional initiatives.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Pfizer? Share your experience