QC Stability Operations Specialist

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

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.

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