Technician - QA Documentation Control-Port Jervis Quality Product Release Hourly Indirect

Company: Knowlton Development Corporation
Location: Port Jervis
Posted on: March 16, 2023

Job Description:

KDC/ONE POSITION DESCRIPTION 3/2022 POSITION CODE 1695 Title: - - - - - - - - - - - - - - - - - - - - - - - - - - Technician- QA Documentation Control Reports to: - - - - - - - - - - - - - - - -Supervisor - QA Document Control Department: - - - - - - - - - - - - - Quality Assurance - Product Release Supervises: - - - - - - - - - - - - - - - - N/A Organizational Relationships: - - - - - - - - - - Direct interaction with analytical, microbiology, and quality laboratory personnel, quality inspection, specification, validation, and ADR personnel. - Also interacts with Business Development Representatives, customer contacts, planning, and all operation personnel. Basic Function: Assures the pharmaceutical product documentation is maintained in compliance with the Food & Drug Administration regulations, 21 CFR, Parts 210 & 211. Responsibilities: - 1. - - - - -Prepares, assembles, and reviews the records of both cosmetic and pharmaceutical product manufacture and packaging for regulatory audits. 2. - - - - -Itemizes deficiencies and communicates deficiencies to appropriate personnel. 3. - - - - -Follows-up on corrective action for timely disposition of bulk and finished goods. 4. - - - - -Review and data correlation of product test results for release of bulk for filling, WIP for packaging, finished goods for shipment. - Data is sourced from analytical, quality, microbiology, inspection, customer contacts and outside testing laboratories. 5. - - - - -Assigns batch codes and sets expiry dates on bulk and finished goods - based on kdc/one/Customer policies and customer portal systems. 6. - - - - -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. 7. - - - - -The position requires defining BatchPak formulation associations with manufacturing procedures, remelt and mold procedures, bulk specifications, and finished goods specifications. 8. - - - - -Executes Micro Exception requests by customer representatives per the customer. 9. - - - - -Submission of bulk "OFA" samples to customer or outside lab for approval /test results. - Position requires good customer service skills in that OFA samples must be tracked-numerous phone calls and e-mails must be made to the customer or outside labs. - OFA response is then communicated internally for batch scheduling, remediation and/or disposition. 10. -Manages the documentation customers require on OTC products. 11. -Compiles the master batch packet for OTC products and maintenance of same for customer audits and regulatory inspections. 12. -Compiles, maintains, and reviews the batch production record packet for OTC products in compliance to current good manufacturing practices. 13. -Any other special projects and duties at the discretion of the supervisor. Qualifications: 1. - - - - -High School Diploma and a minimum of 1(one) year relevant experience 2. - - - - -Ability to read and write English 3. - - - - -Ability to follow written instruction 4. - - - - -Effective communication skills (Customer interaction) 5. - - - - -Effective basic mathematic skill 6. - - - - -Good organizational skills 7. - - - - -Working knowledge of current good manufacturing practices (cGMP). 8. - - - - -Working knowledge of kdc/one procedures as pertains to cGMP compliance. 9. - - - - -Full knowledge of batch coding procedures (kdc/one and Customer) used to code bulk and/or finished goods. 10. -Effective computer skills in Microsoft Word, Excel and BatchPak, QAD. 11.Working knowledge of minimum legal fill of container requirements.

Keywords: Knowlton Development Corporation, Paterson , Technician - QA Documentation Control-Port Jervis Quality Product Release Hourly Indirect, Professions , Port Jervis, New Jersey