GDP Clerk (10pm-6:15am)

at  Captek Softgel International

Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands.
Summary: The GDP Clerk is responsible for daily batch record review, reconciliations & job receipts in SYSPRO.

QUALIFICATIONS:

• 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.
• 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.

EDUCATION/EXPERIENCE:

• High School Diploma or GED equivalent.
• Minimum of 3 years relevant work experience.

QUALIFICATIONS:

• 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.
• 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.

EDUCATION/EXPERIENCE:

• High School Diploma or GED equivalent.
• Minimum of 3 years relevant work experience.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Batch record review (daily):
• Review PBR for GDP (Good Documentation Practices).
• Verify all raw material used on the job Syspro and make any necessary transactions.
• 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.
• Work with Operations to correct all documentation errors prior to release to QA.
• Reconcile the gelatin jobs to the bulk.
• In collaboration with the Production lead, 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.
• Adherence to HACCP and Food Defense.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Batch record review (daily):
• Review PBR for GDP (Good Documentation Practices).
• Verify all raw material used on the job Syspro and make any necessary transactions.
• 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.
• Work with Operations to correct all documentation errors prior to release to QA.
• Reconcile the gelatin jobs to the bulk.
• In collaboration with the Production lead, 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.
• Adherence to HACCP and Food Defense.