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Senior Batch Release Auditor

Pfizer


Location:
McPherson, KS 67460
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

**ROLE SUMMARY**







+ Assemble documentation from all functional areas into sections for process/documentation review.



+ Performs the initial Quality review of all accumulated records that include in-process records, finished product batch records and analytical data packages. The reviews are performed to ensure correct documentation practices, for adequate supporting data and presence / completion of all required steps.



+ Assign corrections to responsible individuals to correct /complete required documentation if identified during the review process.



+ Prepares C of A from the analytical data package and C of M from the batch record.



+ Functions include, organizing batch record packages, filing laboratory records, performing scanning of C of A's, archiving of completed records and destroying expired records.







**ROLE RESPONSIBILITIES**







+ Reviews batch related manufacturing, packaging and analytical records for completeness and acceptable results. Evaluates and assesses acceptability/releasability based on established standards and through mathematical calculations.



+ Requires making decisions of the adequacy of documentation to meet regulatory requirements. If errors, inconsistencies, or deficiencies in documentation are noted, the auditor is responsible for interaction with the respective business unit (Production, Quality Labs, Warehouse, and PIC personnel) for follow-up and corrective action.



+ Set-up and maintain area batch related files.



+ Creates and issues Certificate of Analysis and Certificate of Manufacture for finished products.



+ Enters and manipulates data in various software packages (Access, Word, and others) for task correction and lot tracking purposes.



+ Update SOP's, checklists, and copy checklists as needed.



+ Copy and assemble copied record packages for Third Party customers as specified by the specific customer.



+ Destruction of expired records.



+ Scanning of C of A's



+ Archiving of completed records



+ Maintain the record storage library



+ Interact with internal and external customers for process definition and issue resolution



+ Other duties as assigned







**QUALIFICATIONS**







+ 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)



+ Requires associate degree (2 yr. degree) with higher level math or statistics plus 2 years experience reviewing batch related documentation; OR Certified Quality Auditor or (equivalent) plus 2 years experience reviewing batch related documentation; OR 4 years experience reviewing batch related documentation which included the use of calculating percentages, overages, and accountabilities.



+ Requires competent oral and written communication, strong interpersonal skills, and decision-making skills. Must be able to handle multiple projects. Knowledge of how to use a personal computer is required; with a working knowledge of Word, Access and Paradox. Knowledge of production operations and analytical data records is preferred.







**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: November 7, 2017**



+ **This job is a 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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