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QA Stability & Informa Specialist


Kissimmee, FL 34746
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Job Details

**Closing Date: 22nd February**

**Job Title:** **QA Specialist - Stability & Informa Data Analytics**

**Department:** Quality Assurance

**Position Reports to:** Ciara Treacy

**Job Purpose:**

The role will combine both the creation and maintenance of the Stability program and the implementation of products on Stability onto the Informa system.

**Job Responsibilities:**

This role is focused on providing high quality support both scientific and statistical in support of the Stability program. This is particularly critical in relation to regulatory submissions for products tested at the site. This support includes developing and sustaining the evolving data aggregation and reporting quality control and analysis platform Informa. .

The candidate will need the following:

**Stability** :

+ Facilitate the creation and maintenance of the schedule for completion of the Annual Stability Program.

+ Key role in any atypical or out of specification investigation.

+ Facilitation and technical support for Stability Review Board (SRB) process.

+ Provide technical expertise in the design, implementation and management of stability studies, including relevant documentation, in line with current regulations, PQS and business needs. All related procedures and documentation to be maintained accordingly.

+ Authorship, review & approval of stability sections of regulatory filings.

+ Support the introduction of new products.

+ Trend reviews and SQRT (Site Quality Review Team) updates where required


+ Collaborate closely with key project stakeholders in the quality control environment on the provision of statistical services that support regulatory submissions for stability filings.

+ Provide statistical support when required during investigations, new product introduction or change implementation. Technical support may involve trouble-shooting and analysis to support identification of root cause.

+ Provision of solutions that lead to colleagues being able to conduct their own data analyses rather than using statisticians.

+ Developing performance analytical solutions for continuous and time series data produced during batch processing.

+ Support data aggregation solutions for continuous and time series data analysis.


+ Safety and housekeeping considerations

+ Execute responsibilities in line with Right First Time principles

+ Ensure resolution of and/or appropriate escalation of issues

+ Demonstrating company values and Pfizer competencies

+ Ensure that all department metrics are adhered to and reported on time.

+ Provide subject matter expertise and support for systems, technologies and products.

+ Identify Continuous Improvement opportunities and progress Continuous Improvement projects.

+ Participate in decision making in consultation with relevant stakeholders

+ Ensure strict adherence to site policies/procedures, cGMP and environmental, health and safety regulations.

+ Area/departmental weekly/monthly reporting.


+ Third level degree in a science related field, statistics, biostatistics, computer science, engineering or related field is advantageous.

+ Strong technical writing skills.

+ Knowledge of statistical tools, languages and methodologies (6-Sigma, Process capability, R, Python etc.) and associated software packages.

+ Capability to provide statistical guidance to cross-functional teams is advantageous.

+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organisation.


+ Strong interpersonal skills with an ability to work independently across sites and teams.

+ Highly motivated, proactive and persistent.

+ Demonstrates a 'can do' attitude.

+ Self-aware.

+ Adapts to change, responds positively with a sense of urgency.

+ Effective communication (verbal & written).

+ Ability to matrix-work effortlessly across team and organizational/hierarchical boundaries.

+ A team player by preference.


+ Please submit CV on Workday

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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