Responsible for reviewing and approving quality investigations and associated documentation. Assures that quality documentation meets cGMP and regulatory requirements to assure safety, identity, strength and quality of the product and associated processes. RESPONSIBILITIES: Review and approve exception investigation documentation. Provide guidance identifying potential product impact and determine final product disposition through exception report approval. Provides 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 improvement of the system of quality investigations. Provide real-time guidance on event classification and proper actions to mitigate and limit potential product impact. Manage day to day tasks/deliverables to meet expected due dates for Interim Reports, CAPA closure, etc. QUALIFICATIONS: Bachelor's Degree required, scientific field preferred; A minimum of 3 years professional experience in Quality or Operations, primarily in a cGMP facility, or equivalent is needed to meet the objectives of this position. Requires thorough knowledge of cGMPs. Effective communication skills are required, both written and verbal. Effective project management skills and demonstrated ability to manage multiple competing priorities Analytical ability is required to make competent decisions based on a review of an investigation and supporting analytical data. Sound analysis is required to ensure effective CAPA activities. 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: 10/17/2017 This job is a Hospira Exempt US Grade: 016 Eligible for Relocation Package A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.