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.
Qualifications
Must-Have
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
Nice-to-Have
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:
The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
Quality Assurance and Control
