Batch Record Specialist

Employer
Pfizer
Location
Rocky Mount, North Carolina
Posted
Jul 30, 2021
Ref
4819155
Required Education
High School or equivalent
Position Type
Full time

ROLE SUMMARY

The 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, 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, RDOCS, LIMS and gLIMS, with List number, Lot Number, and Product Name and any notes regarding One2One customers on the batch record footer.

  • Prints, assembles, and issues the production batch records based on the Materials Management production schedule, utilizing systems, AS400, RDOCS, LIMS, gLIMS 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.

  • Perform annual master file audits on satellite files and documents.

  • Maintenance of the site log book program, including issuance, storage, retrieval, and archiving of site log books.

  • Storage processing of site documentation to off-site storage facility

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

BASIC QUALIFICATIONS

  •  High School Diploma and 3 years’ experience in a controlled document management/records management environment

  • An Associate’s degree with 1 year experience in a controlled document management/records management environment.

  • Strong attention to small details and maintain a high degree of accuracy

  • Thorough knowledge of cGXP

  • Knowledgeable in AS400 and rDocs HPI system.

  • Proficient in Microsoft Office (Word, Excel)

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

  • Strong reading comprehension and proofreading skills, strong organizational skills

  • Excellent written and verbal communication skills

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

  • Ability to facilitate process improvements

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

PREFERRED QUALIFICATIONS

  • Proficient in SAP, PDOCS, LIMS, gLIMS, AMPS and ALPS system.

PHYSICAL/MENTAL REQUIREMENTS

  • Requires ability to work at desk on computer for long periods of time ~ 4 hours.
  • Requires the ability to lift paper and bending over to maintain printers.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Weekend work to meet production and validation schedule
  • Overtime work to meet production and validation schedule
  • On call rotation to cover weekend issues

Other Job Details:

  • Last Date to Apply for Job: July 30, 2021

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.

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.

Administrative

#LI-PFE