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  • Job Title
  • Sr. Quality Specialist
  • Location
  • Irvine
  • Job Number
  • 127806
  • 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: Sr. Quality Specialist, Compliance
Location:Irvine, CA
Compensation: $35 to $38/ hour (DOE)

POSITION SUMMARY:

The Senior Quality Specialist, Compliance is responsible for independently planning and conducting activities that ensure the plant’s compliance to cGMPs and regulations as well as internal quality procedures. Supports quality efforts across the Company and the Endo enterprise to ensure a state of constant readiness for inspections at the site. In order to maintain preparedness, this role audits and assesses the performance of the facility against regulations and internal requirements. Identifies compliance issues and support the implementation changes for constant improvements. Ensures adherence to SOPs and policies and assists the Compliance Manager in ensuring that procedures reflect current practice.

Provides subject matter expert (SME) consultative support for all regulatory audits, internal and external inspections, and other audits. Leads cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards. Implements a self-inspection program and evaluates metrics to determine trends and opportunities for continuous improvements and liaises with QS&T and other departments.

ROLE AND RESPONSIBILITIES:

  • Independently audits and evaluates quality systems and practices to identify potential problems and coordinate resolutions
  • Implements a self-inspection program to include inspection of procedures, audit schedules, audit reports and observation follow-up and closure
  • Provides guidance on quality/compliance improvements
  • Prepares summaries and reports based on internal audits, outlining improvements and performance against audit findings
  • Ensures adherence to SOPs and policies
  • Ensures that procedures reflect current practices and policies
  • Reviews documents for compliance to current regulations and cGMPs
  • Provides SME consultative support for all regulatory audits, internal and external inspections, and other audits
  • Maintains FDA Readiness Plan for the facility
  • Plans and participates in mock inspections to prepare the facility for audits and assesses gaps in the system
  • Leads cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards
  • Evaluates metrics to determine trends and opportunities for continuous improvements and liaises with QS&T and other departments
  • Provides accurate metrics to the QS&T department

REQUIRED QUALIFICATIONS:

  • Minimum of BA/BS preferably in life sciences with a minimum of 6+ years’ experience in the pharmaceutical industry
  • Auditing experience against cGMP
  • Regulatory Inspection experience required
  • Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA
  • Strong 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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