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SrAssociat GoodLabPract


Groton, CT
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Job Details

**Role Summary:** **The Good Laboratory Practices Quality Assurance Senior Associate is responsible for the delivery and execution of local and global Quality Assurance (QA) program audit activities on assigned projects/products/programs. This role is responsible for Good Laboratory Practices (GLP) and/or Good Clinical Laboratory Practices (GCLP) oversight, and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).**

**Role Responsibilities:**

**Risk/Quality Management:**

+ Interacts with QA colleagues at other Pfizer locations to ensure consistency in application of the QA strategy and to promote standardization of auditing approach within QA

**Operational Excellence:**

+ Conducts scheduled audits in accordance with Quality Assurance (QA) risk-based processes

+ Assesses compliance of GLP research studies and facility activities, data, and reports against applicable government agency regulations/ guidelines, as well as Pfizer policies, procedures and industry standards

+ Demonstrates a working knowledge of concepts and principles of Quality Assurance and baseline auditing

+ Conducts QA audits, reports results to responsible personnel and management, and interacts with various teams to ensure corrective actions are taken to bring QA observations to closure as applicable

+ Responsible for audit preparation and notification to key stakeholders (e.g. review of audit and inspection history and SOPs)

+ Conducts audits of GLP laboratory studies, business processes, facilities and vendors (as necessary)

+ Conducts audits of regulatory documents (as necessary)

+ Applies basic team effectiveness skills and knowledge and participates in local operational teams with basic understanding of customers

+ Applies basic working knowledge of SOPs (Standard Operating Procedures), GLP (Good Laboratory Practices), regulations and guidelines as well as local regulations

+ Generally contributes toward internal customer needs by providing GLP advice

+ Ensures rapid communication of QA issues, including potential misconduct or issues of significant deviation with projects/products, to appropriate leaders and colleagues

+ Demonstrates ability to work in a culturally diverse environment

+ Demonstrates OWNIT! behaviors


+ Bachelor's degree or equivalent experience

+ 3-5 years relevant experience in the pharmaceutical industry or related field (i.e. clinical research, previous audit experience, previous experience in a quality role position, etc.)

**Travel Required:** Requires approximately 60% time for conducting audits (including travel) and attending QA meetings. The travel requirement may be up to 15% **Organizational Relationships**

+ Reports to aligned GLP Quality Assurance Site Lead or GLP Lead.

+ Works closely with other QA functions in matrix-management principles.

+ Partners with other QA functions to assure consistent professional and appropriate QA support across project and audit needs.

+ Internal interfaces include: All functions within QA and across Divisions; Research Units, Business Units, and Partner Lines including Corporate Audit and other quality organizations within Pfizer

+ External interface: Works with external contacts, which may include regulatory agencies, pre-clinical study investigators, vendors, licensing partners and professional scientific and quality groups

**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.

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: February 1, 2018**

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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