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Qa Auditor

Pfizer


Location:
McPherson, KS 67460
Date:
11/03/2017
2017-11-032017-12-04
Pfizer
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Job Details

**ROLE SUMMARY**



Performs multiple functions in support of production and release of finished products. Ensures quality of finished product through appropriate sampling, testing and evaluation as well as accuracy and completeness of batch record and audit documentation. All tasks are to be completed in a timeframe that facilitates the most efficient release of batches possible.







**ROLE RESPONSIBILITIES**







+ Completion and comprehension of all Standard Operating Procedures and Training Course Plans required for the position of MQ Auditor. This includes many procedures for all manufacturing lines as well as other areas in the plant including but not limited to Laboratories, Validation, Documentation, and Materials Management. Maintain a satisfactory record of completion of ISOTrain requirements.



+ Audit compliance of product and processes against written specifications, Standard Operating Procedures, Monographs, and current Good Manufacturing Practices. This is accomplished by use of statistical acceptance sampling plans, written test procedures, observation of production processes, and evaluation of written documentation. Requires interpretation of established standards and utilizes judgement regarding conformance of components, processes and finished products. Manual light test audits and packaging observations are performed to determine product acceptability. Classification of any defects or deviations found during production process. Any deviation from established specifications or Standard Operating Procedures must be effectively and professionally communicated to affected business units (Production, Quality Laboratories, Materials Management, Financial Systems, Contract Manufacturing, Engineering, and Documentation personnel) as well as Manufacturing Quality supervision and management. Assist in the investigation of deviations to aid supervisory personnel and management in undertaking corrective actions or recommendations. Generate On Hold notices when necessary to prevent further processing or release of batches until investigations are complete.



+ Set up audit packages including documentation pages for light test audits and packaging inspections. Generate and compile documentation of all steps taken related to the manufacture, testing and packaging of manufactured products. Review and assess batch-related manufacturing, auditing and packaging documentation for acceptance based on established standards and through mathematical calculations. Enter and manipulate data in various software packages (Paradox, Access, Word, Excel, and others). Trend audit data in written and computer-based logs for future reporting and tracking purposes.



+ Requires decision making of the adequacy and accuracy of documentation to meet regulatory requirements. If errors, inconsistencies, or deficiencies in documentation or processes are noted, the auditor is responsible for elevating the issue to appropriate management. May be tasked to complete interaction with the respective business units for follow-up and corrective action. Any deviation from established specifications or Standard Operating Procedures must be effectively and professionally communicated to affected business units as well as Manufacturing Quality supervision and management. Assist in the investigation of deviations to aid supervisory personnel and management in undertaking corrective actions or recommendations.



+ Research sampling requirements, create sampling records and perform in-process sampling of batches for reserve sample retains as well as stability and sterility samples. Retrieve samples requested by Special Sample Request forms from in-process product as well as finished product through coordination with Materials Management department. Store and/or deliver all samples to appropriate storage conditions or laboratory.



+ Perform daily monitoring and review of charts which record data in temperature and humidity controlled locations. Generate Notification of Specification Excursion reports when temperature readings are out of specification for an unacceptable period of time. Coordinate the needed corrective action with affected business units (Quality Laboratories, Materials Management, Contract Manufacturing and Engineering). Track investigation and completion of Excursion reports. Maintain long-term storage of statistical charts for required period of time and for future use in 3rd Party Audits, Regulatory Audits and Internal Assessments.



+ Perform light intensities for all light test stations throughout the plant to ensure equipment meets requirements for testing purposes.



+ Generate Line Clearance Event Notification forms when a line clearance violation has been identified. Assist in the investigation of the violation found on a production line or within the plant. Notify all applicable supervisors and management.



+ Assist in the coordination of controlled and uncontrolled product inventory. Perform periodic audits of product inventory to ensure compliance of product and processes against written specifications, Standard Operating Procedures and current Good Manufacturing Practices.



+ Participate in the Internal Assessment program as a team member. May participate in Internal Assessment program as team leader if approved.







**QUALIFICATIONS**







+ Minimum: Requires enough basic education to understand and follow standard practice or oral instruction, use simple arithmetic, keep simple records, or use simple office machines. (Up to and including high school)



+ Preferred: Requires ability to understand and carry out assigned duties effectively. Knowledge needed of specialized business processes such as elementary accounting procedures, operation of equipment such as bookkeeping and billing machines, basic computer operations and normal office procedures. (High school plus additional specialized courses or experience)







**PHYSICAL/MENTAL REQUIREMENTS**







+ Requires competent oral and written communication, strong interpersonal skills, and decision-making skills. Must be able to handle multiple projects with impeccable accuracy while managing frequent interruptions. Knowledge of use of a personal computer is required with a working knowledge of Word, Access, Paradox and Excel. Knowledge of applicable Production, Quality Laboratories, Materials Management, Financial Systems, Contract Manufacturing, Engineering, and Documentation processes are required. Must have 20/20 correctable vision. Required to do occasional lifting in excess of 25 pounds.







**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: November 15, 2017**



+ **This job is Hospira Non-exempt US Grade: 10**







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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