Hiring company: Pfizer
ROLE SUMMARY
The Batch Record Specialist manages the printing and assembly of production batch records based upon the Materials Management manufacturing schedule for SVP (R1/R2/R3). They are responsible for assuring accurate, complete document printing for each stage of product processing. As well as assuring that all batch records that require 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, AMPS 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, AMPS, 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.
- 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 AS400, SAP, rDocs, PDOCS, 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: November 22nd 2021
- Eligible for Relocation Assistance: No
- Eligible for Employee Referral Bonus: YES
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.