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Quality Investigations Approver


Rocky Mount, NC
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Job Details

The **Quality Investigations Approver** is responsible for reviewing and approving quality investigations (QARs, Events, LIRs and RAACs) and associated documentation (Interim reports, corrective and preventive actions). The Quality Investigation Approve is responsible for assessing potentially impacted product to ensure it meets cGMP and regulatory requirements to assure safety, identity, strength and quality. The Quality Investigation Approve provides guidance on impacted product disposition based on the investigation. He/she is responsible for assuring that investigations are written in accordance with site requirements and are robust, stand-alone documents based on logic and the appropriate use of investigation tools.

+ Review, provide comments, and disposition investigation documentation.

+ Provide guidance identifying potential product impact and determine final product disposition through report approval.

+ Provide guidance on remediation and developing corrective and preventive action (CAPA) plans.

+ Lead the successful closure of CAPAs through collaboration with peers in operations and other departments.

+ Function as a quality representative as needed supporting the reduction of event initiation and continuous improvements of the system of quality investigations.

+ Provide real-time guidance on event classification and proper actions to mitigate and limit potential product impact.

+ Assist with internal, third party, and Federal/State audits, including FDA audits, as applicable.

+ Maintain current in all required training.

+ Perform special assessments and assignments as required.

+ Demonstrated knowledge of Quality Management Systems.

+ Demonstrated experience with cGMP and all applicable regulations associated with the manufacturing of Rocky Mount products.

+ Strong administrative and communication skills are required, verbal and written.

+ Effective leadership skills, the ability to manage multiple competing priorities, multitask and work efficiently in a dynamic, ever changing manufacturing


+ Bachelor's degree preferably in a scientific or technical field

+ Minimum of 3 years professional experience in Quality or Operations, primarily in a cGMP facility environment.

**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.

**Last Date to Apply for Job:** February **6, 2018**

Eligible for Relocation Package

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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