GDP Clerk 3rd shift
GDP Clerk 3rd shift
Summary: The GDP Clerk is responsible for daily batch record review, reconciliations & job receipts in SYSPRO. Additional duties will include various production support functions as needed.
Shift Schedule: Monday to Friday 10:00 pm to 6:30am
Essential Duties and Responsibilities:
• Batch record review (daily):
o Review PBR for GDP (Good Documentation Practices).
o Verify all raw material used on the job against syspro and make any necessary transactions.
o Reconcile the gelatin used on the job to the gelatin tags attached to the PBR.
• Creation of job receipt in SYSPRO and submission of PBR (Production Batch Record) to QA.
• Update the PBR Report on a daily basis and email it to respective departments.
• Reconcile the gelatin jobs to the bulk.
• In collaboration with the Production Coordinator, review and reconcile gelatin batch records.
• Apply Encapsulation Fee to all jobs on a daily basis.
• Update Encapsulation Fee report on a daily basis.
• Initiate low yield NCR’S.
• Keep track of availability of Nitrogen tanks and place orders as needed.
• Get quotes and order printing cylinder rolls and artwork as requested by Customer Service.
• Prepare the monthly Absorption Report with the jobs encapsulated in the month.
• Attend daily MPS meeting.
• Update the attendance log on a on a daily basis.
• Minimum educational qualification – High School Diploma or GED equivalent.
• Minimum of 3 years relevant work experience.
Required Skills / Experience:
• Good communication skills both written and verbal
• Ability to set priorities, be flexible, multi-task, and meet deadlines
• Ability to develop and maintain professional relationships with internal and external stakeholders.
• Proficiency in Microsoft Word, Excel, and Outlook.
• Experience working with ERP systems and SYSPRO experience preferred
• Working knowledge of cGMPs and FDA regulations
• Highly organized and detail oriented with the ability to work effectively in a fast paced work environment.
•The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles and risk of electrical shock.
•The noise level in the work environment is usually moderate.
•The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.