Technician - Documentation Control

KDC One • Port Jervis, NY

1d

About The Position

Assures the pharmaceutical product documentation is maintained in compliance with the Food & Drug Administration regulations, 21 CFR, Parts 210 & 211. This role involves preparing, assembling, and reviewing records of cosmetic and pharmaceutical product manufacture and packaging for regulatory audits. It also includes itemizing deficiencies, communicating them to appropriate personnel, and following up on corrective actions for timely disposition of bulk and finished goods. The position requires reviewing and correlating product test results for the release of bulk for filling, WIP for packaging, and finished goods for shipment. Data is sourced from analytical, quality, microbiology, inspection, customer contacts, and outside testing laboratories. The technician assigns batch codes and sets expiry dates on bulk and finished goods based on kdc/one/Customer policies and customer portal systems. They also effect the disposition of cosmetic products on the QAD system. The process entails changing the status of bulk (inspect, approve, reject), verifying manufacturing transfer weight data, verifying and reporting packaging yield data, and effecting the positive release of finished goods. The position requires defining Batch Pak formulation associations with manufacturing procedures, remelt and mold procedures, bulk specifications, and finished goods specifications. It also involves executing Micro Exception requests by customer representatives per the customer and submitting bulk “OFA” samples to the customer or outside lab for approval/test results. The role requires good customer service skills for tracking OFA samples, making numerous phone calls and emails to customers or outside labs, and communicating OFA responses internally for batch scheduling, remediation, and/or disposition. The technician manages the documentation customers require on OTC products, compiles the master batch packet for OTC products and maintains it for customer audits and regulatory inspections, and compiles, maintains, and reviews the batch production record packet for OTC products in compliance with current good manufacturing practices. All other duties as assigned.

Requirements

• High School diploma or equivalent.
• A minimum of 1 year of relevant experience.
• Ability to read and write English
• Ability to follow written instruction
• Effective communication skills (Customer interaction)
• Effective basic mathematic skill
• Good organizational skills
• Working knowledge of current good manufacturing practices (cGMP).
• Working knowledge of kdc/one procedures as pertains to cGMP compliance.
• Full knowledge of batch coding procedures (kdc/one and Customer) used to code bulk and/or finished goods.
• Effective computer skills in Microsoft Word, Excel and BatchPak, QAD.
• Working knowledge of minimum legal fill of container requirements.

Responsibilities

• Prepares, assembles, and reviews the records of both cosmetic and pharmaceutical product manufacture and packaging for regulatory audits.
• Itemizes deficiencies and communicates deficiencies to appropriate personnel.
• Follows-up on corrective action for timely disposition of bulk and finished goods.
• Review and data correlation of product test results for release of bulk for filling, WIP for packaging, finished goods for shipment.
• Assigns batch codes and sets expiry dates on bulk and finished goods – based on kdc/one/Customer policies and customer portal systems.
• Effects disposition of cosmetic products on QAD system.
• Defines Batch Pak formulation associations with manufacturing procedures, remelt and mold procedures, bulk specifications, and finished goods specifications.
• Executes Micro Exception requests by customer representatives per the customer.
• Submission of bulk “OFA” samples to customer or outside lab for approval /test results.
• Manages the documentation customers require on OTC products.
• Compiles the master batch packet for OTC products and maintenance of same for customer audits and regulatory inspections.
• Compiles, maintains, and reviews the batch production record packet for OTC products in compliance with current good manufacturing practices.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED