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Documentation Batch Record Specialist

Pfizer


Location:
Rocky Mount, NC
Date:
11/17/2017
2017-11-172017-12-18
Pfizer
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Job Details

The **Documentation Batch Record Specialist** manages the printing and assembly of production batch records based upon the Materials Management manufacturing schedule. The batch record specialist is responsible for assuring accurate and complete document printing for each stage of product processing. The batch record specialist assures that all documents, required tickets, labels, sample requests, stability paperwork, and additional testing requirements are included in the package. They are responsible for communicating with Materials Management, Engineering, and Validation on list numbers that are flagged for manufacturing holds or have "manufacturing on risk" designations, which create scheduling concerns. They work closely with the department List Number Specialists to resolve/explain hold or risk issues and with production on special printing requests.







**ROLE RESPONSIBILITIES**







+ Update systems related to batch record product, AS400 and LIMS, with List number, Lot Number, and Product Name and any notes regarding PC1 customers on the batch record footer. Explodes and releases lots within AMPS.



+ Prints, assembles, and issues the production batch records based on the Materials Management production schedule, utilizing systems, AS400 and Work Order Tracking.



+ Performs the weekly assignment of the production schedule to the responsible Batch Record personnel and daily assignment of schedule changes.



+ Monitors and quickly reacts to schedule changes that are received multiple times a day, including reworks, retrieving issued packages as necessary, and issuing the changes promptly.



+ Performs annual master file audits on satellite files and documents.



+ Maintenance of printers, notifying IT when issues occur; and provide inventory of paper and form stock to meet department needs.







**QUALIFICATIONS**







+ High School Diploma and 3 years' experience in controlled document management/records management position required



+ Associates degree, an additional 1 year experience in controlled document management/records management position required



+ Thorough knowledge of cGXP



+ Proficient in AS400, LIMS, AMPS, and rDocs HPI system.



+ Proficient in Microsoft Office (Word, Excel)



+ Ability to work independently and multi-task in a fast, priority -switching environment



+ Strong attention to detail and excellent written and verbal communication skills



+ Strong reading comprehension and proof reading skills, strong organizational skills



+ Demonstrated ability to work/contribute in a team-based environment



+ Team and customer oriented



+ Ability to facilitate process improvements



+ Ability to load printers, lift paper stock and limited ability to troubleshoot printer.







**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 4, 2017**



+ **This job is Hospira (Non-exempt) US Grade** **: 04**







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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