Batch Record Specialist
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.
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.
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.
- Proficient in SAP, PDOCS, LIMS, gLIMS, AMPS and ALPS system.
- 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