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Sr. Internal Compliance Auditor


Rocky Mount, NC
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Job Details

Job Title Sr. Internal Compliance Auditor

JobID 1614066

Location: Rocky Mount, NC

Description The Senior Compliance Internal Lead Auditor coordinates, administers, and implements the quality systems audit program to assure the product is manufactured in compliance with established regulations and Hospira quality procedures. These activities include the development, implementation, and monitoring of quality auditing and associated activities to ensure the manufacture and distribution of pharmaceutical products are compliant with FDA regulatory requirements and foreign regulatory bodies. The Auditor organizes and leads a team of auditors for all internal audits. This requires the Auditor to evaluate problems objectively, evaluate existing procedures and guidelines, analyze data and prepare evaluations, and ensure proper actions are implemented. The Sr. Compliance Internal Lead Auditor evaluates for root cause, assesses corrective actions, and works with site management to assure CAPA effectiveness. Responsible for providing technical support to Quality Management as an outcome of audit findings and elevates issues to management, as appropriate. The Sr. Compliance Internal Lead Auditor will be responsible for coordinating all internal audits per year. These audits will be conducted in all areas of the facility - including but not limited to Quality Systems, Quality Assurance, Quality Control, Quality Operations, Manufacturing Operations, Supply Chain, Validation, Engineering, MS&T, etc. The scope of the internal audits cover all systems and subsystems, such that issues are identified and corrected in-house prior to identification by a regulatory body and to be quick to detect and evaluate problems objectively, evaluate existing practices, procedures and guidelines, analyze data and prepare evaluations, and ensure proper actions are implemented.

+ Facilitates internal audits as the lead auditor with a team of auditors to access the facility's compliance of existing regulations and new regulations.

+ Evaluates applicable corrective and preventive action responses to the audit findings for adequacy and timeliness. Assesses and approves closure of CAPAs within the gQTS CAPA Management system as the QA Approver for both internal and external audits.

+ Supervises and assists Auditors in sustaining the facility's cGMP compliance by administering more cGMP audits throughout the facility on various shifts.

+ Performs trending analysis of audit observations or compliance issues and address trending issues with appropriate personnel for resolution.

+ Tracks regulatory agency and 3rd party inspection commitments.

+ Supports all compliance responsibilities.

+ Ensures preparation, revision, and implementation of relevant SOPs.

+ Supports updates of the site Quality Manuals for drug and device products, the site master file, and Management Review.

+ Participates in regulatory inspections and third party audits, as appropriate.

+ Participates in the development and delivery of auditor training, regulatory inspection preparedness training, and continuous improvement.

+ Support the DEA Program Lead with the site controlled substance program.

+ Manages metrics of internal audits for SQRT.


+ Bachelor's Degree required.

+ Minimum of 5 years of experience in a FDA regulated environment.

+ Auditing experience preferred.

+ Minimum of 5 years of experience in one or more of the following:

+ Quality Engineering/compliance/Regulatory Affairs

+ Manufacturing/Technical experience in Pharmaceutical or GxP regulated environment

+ ASQ Certification preferred. Certification will be required within 2 years of hire.

+ Internal Lead Auditor certification within 1 year of hire.

+ Demonstrated ability to lead and also participate as a member of a team with exceptional interpersonal skills and demonstrated problem-solving skills.

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

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

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

+ May be required to stand for extended period of times during audit tours. Will be required to gown for production during audits.

**EEO & Employment Eligibility**

Pfizer is committed to equal opporstunity 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.

**Additional Offer Details:**

+ **Last Date to Apply for Job: September 22, 2017**

+ **This job is Hospira Exempt US Grade** **:16**

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.

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