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Compliance Associate

Pfizer


Location:
McPherson, KS 67460
Date:
01/12/2018
2018-01-122018-02-12
Pfizer
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Job Details

**ROLE SUMMARY**



The Compliance Associate -Inspection Readiness serves as the primary support for all regulatory inspection activities at the McPherson site, including preparation activities and follow-up. This role is vital to ensure ongoing compliance to regulatory expectations. The incumbent will assist with regulatory inspections, as well as manage and participate in projects designed to increase the compliance profile of the site.







**ROLE RESPONSIBILITIES**







+ Primary support for all inspection related activities at the site including preparation, back room assistance, response drafting, and commitment tracking and follow-up.



+ Work closely with front room hosts during an inspection to pull requested information and organize appropriate Subject Matter Experts to interact with regulatory inspectors.



+ Assist in back room for customer audits, pulling requested information and organizing Subject Matter Experts.



+ Primary responsibility for inspection readiness activities, including monitoring of facility audits and walkthroughs, monitoring of regulatory guidance updates, and review of sister-site inspectional observations to evaluate for potential gaps.



+ Support of Quality Compliance Data Integrity initiatives, including project management and maintenance.







**QUALIFICATIONS**







+ Bachelor's Degree in Science or related field



+ Minimum 3 years of experience in pharmaceutical industry or equivalent



+ Familiar with regulatory requirements and guidance



+ Excellent communication skills and attention to details







**PHYSICAL/MENTAL REQUIREMENTS**







+ No unique physical requirements



+ Mental:



+ Remain organized and positive in a fast-paced, rapidly changing environment



+ Ability to analyze data from multiple sources and utilize risk management tools



+ Interface effectively and develop positive relationships with all levels of the organization



+ Able to appropriately manage ambiguity and work autonomously







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Limited to no travel required. Occasional non-standard work hours to support regulatory inspection activities required when needed, though not typical of weekly requirements.







**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: January 25, 2018**



+ **RELOCATION WILL BE PROVIDED**







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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