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:
Work Location Assignment: On Premise
Last day to apply: April 2nd
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
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.