Documentation Control Technician 8:00am-4:30pm - Port Jervis, United States - kdc/one Port Jervis

kdc/one Port Jervis

Verified Company

Port Jervis, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

KDC is a network of best-in-class custom formulators and manufacturers of color cosmetics, skincare, haircare, bath & body, fragrance, deodorant, home, health, industrial, and auto care products.

KDC delivers high-touch innovation, operational excellence, and speed to market to well-known and emerging beauty, personal, and specialty companies from coast to coast.

KDC has its head office in Longueuil, Québec. In addition, KDC has 10 operating facilities located throughout North America. Altogether, the company employs nearly 4,800 talented and dedicated employees in North America.

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:

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.
Followsup 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. Data is sourced from analytical, quality, microbiology, inspection, customer contacts and outside testing laboratories.
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.

The position requires defining BatchPak 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.
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 to current good manufacturing practices.
Any other special projects and duties at the discretion of the supervisor.

Qualifications:

High School Diploma and 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.

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.

Pay:
From $17.00 per hour

Benefits: