Technician - Documentation Control

Essential Duties and 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.
• Process entails: Change status of bulk—inspect, approve, and reject; Verify manufacturing transfer weight data; Verify and report packaging yield data; Effect positive release of finished goods.
• 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.

Minimum Qualifications

• A High School diploma or equivalent.
• A minimum of 1 year of relevant experience.

Knowledge, Skills and Abilities

• Ability to read and write English.
• 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.

Benefits

KDC-ONE is an equal opportunity employer and does not discriminate on the basis of race, religion, color, national origin, age, sex, gender, disability or any other characteristic protected by law.

I understand that employment with KDC-ONE Company is at-will, meaning that I or KDC-ONE Company may terminate my employment at any time, or for any reason consistent with applicable state or federal law.

I understand that KDC-One requires the successful completion of a drug and/or alcohol test as a condition of employment.