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  • Job Title
  • Quality Associate III
  • Location
  • Irvine
  • Job Number
  • 127817
  • State
  • California
  • Job Class
  • Contract/Temp
  • Category
  • Manufacturing
Job Description
A leading Pharmaceutical Manufacturing Company is Hiring individuals with Sharp Detail-Oriented Skills!

The Company is looking for people that share the same passion to make a difference to the health of millions of people globally.
Your expertise will help bring life-enhancing products to the people you know and love!

Title: Quality Associate III / Document Control
Location:Irvine, CA
Work Hours:6am to 2:30pm
Compensation: $23 to $26/ hour (DOE)

POSITION SUMMARY:

The Quality Associate III, Document Control follows applicable SOPs and requirements to maintain a controlled environment. Tracks status of documents to ensure timely review and approval. Works with cross-functional teams as well as external manufacturers and suppliers to ensure change management and documentation requirements are clearly understood and followed. Works cross-functionally to resolve complex quality issues regarding documentation and change management. Works in more complex areas of Document Control including APR documents, the Electronic Document Management System (EDMS), and management of documents during regulatory inspections. Provides guidance to Document Control staff. Trains Quality Associates I and II, Document Control. Works with the team in maintaining a collaborative environment.

ROLE AND RESPONSIBILITIES:

  • Secures and collates documents needed for APR and regulatory submissions
  • Manages document issuance and returns process during regulatory inspections
  • Performs Master Control Administration; resolves questions and issues
  • Ensures rationale for any changes is accurately documented
  • Contacts employees to resolve any issues with submitted documents and works with employees to ensure change management requirements are met
  • Manages documents as system Admin within EDMS
  • Performs technical review of documents during Doc Control phase of EDMS
  • Tracks the status of documents in Master Control and contacts employees to ensure timely completion of changes
  • Manages distribution and reconciliation of official copy documents
  • Participates in resolving complex issues
  • Issues and maintains controlled document numbering system
  • Issues batch records and associated forms
  • Issues Logbooks to departments as needed
  • Maintains batch history log
  • Maintains electronic repository of multi-departmental files of controlled documents
  • Verifies and reconciles controlled documents (logbooks, BPRs, forms, etc.)
  • May enter data from manufacturing into tracking databases
  • Sends/retrieves off-site archived controlled documents; maintains inventory tracking logs
  • Retrieves documents for issuance and returns during regulatory inspections
  • Collaborates with cross-functional departments and CMOs to resolve complex quality issues relating to documentation and change management
  • Becomes a Qualified Trainer and trains junior/peer Quality Associates
  • Retrieves documents for other departments and either makes copies of those documents or scans the documents to the requestor

REQUIRED QUALIFICATIONS:

  • High school diploma or equivalent with 4-7 years’ relevant experience OR
  • AA/AS degree with 3-6 years’ relevant experience
  • Certification in assigned area or related discipline is a plus
  • Has strong knowledge & understanding of cGMPs
  • Understands applicable procedures & documentation SOPs
  • Has knowledge of all current federal, state and local standards and regs, e.g., cGMP, OSHA, DEA
  • Working knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines


***How to Apply:
Please email your Resume to lakeforest@kimco.com or Call Us at 949-855-0300.


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