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Compliance Coordinator


Rocky Mount, NC
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Job Details

The **Compliance Coordinator** coordinates, administers, and implements the quality systems audit response program for regulatory agencies and external customers. These activities include the evaluation of audit observations, development of action plans with area management, implementation of CAPAs, and associated activities to ensure the manufacture and distribution of pharmaceutical products are compliant with FDA regulatory requirements and foreign regulatory bodies. This requires the auditor to evaluate problems objectively, evaluate existing procedures and guidelines, analyze data and prepare evaluations, and ensure proper actions are implemented. This position includes evaluating for root cause, assessing corrective actions, and working with site management to assure CAPA effectiveness to meet regulatory and customer requirements. This position provides technical support to Quality Management as an outcome of audit findings and elevates issues to management, as appropriate. The Compliance Coordinator is responsible for tracking progress of all regulatory, corporate, assessment commitments and assessing the risk for on-time completion. This individual provides visibility to open regulatory commitments to upper management. This position requires sufficient experience and judgment to enable necessary planning to accomplish stated audit commitments. This position will support all activities associated with the site Inspection Readiness and Quality Improvement Plan sponsored by the Quality Excellence Team.


+ Bachelors Degree

+ 7 to 9 years of related experience in an FDA regulated work environment.

+ Demonstrated ability to work/contribute in a team-based environment as a lead and a participant with exceptional interpersonal skills and adept problem-solving skills.

+ Thorough knowledge and understanding of pharmaceutical regulations and guidelines, including but not limited to cGMPs, GLPs, ICH, USP, FDA and other applicable industry guidelines.

+ Strong organizational, presentation, meeting facilitation and technical writing skills.

+ Possess attention to detail and good communication skills as verbal and written feedback to lab staff is required when issues are discovered during document auditing.

+ Strong computer proficiency skills in MS Office, Word, Excel, Project, Trackwise (ER / LIR), and Empower Lims System or equivalent.

**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: December 16, 2017**

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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