Site Quality Associate

Metro Logics•Las Vegas, NV

5d•Onsite

About The Position

The Site Quality Associate is responsible for coordinating, supporting, and maintaining the local site’s compliance quality programs in the cGMP-regulated environment. Occasional out-of-town travel is required.

Requirements

A minimum of 5 years of progressive experience in quality or auditing reporting to a Quality or Regulatory unit within a pharmaceutical or medical device cGMP industry is required.
Candidates must have a Bachelor’s degree or at least four years of supervisory or “team lead” experience in the cGMP industry, reporting to a Quality or Regulatory unit.
Relevant experience and/or advanced training, or an equivalent combination of education and experience, will be considered.
Knowledge of cGMP and other governmental regulations is required.
Comprehensive understanding of quality systems, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other governmental regulations.
Must be able to work efficiently and effectively and remain self-motivated.
Capability to work independently or collaboratively with various teams across the organization while managing multiple projects simultaneously.
Excellent written and verbal communication skills, analytical abilities and interpersonal skills.
Technical writing is required.
Attentive to details.
Must have a satisfactory background screening, negative drug test, positive references and proof of identity and legal authorization to work in the United States are required.

Nice To Haves

Other industry certification, such as Certified Quality Auditor (CQA) or similar, is preferred.

Responsibilities

Supports cGMP systems and operations, as follows:
Interacts with regulated departments, inventory, maintenance, and IT, to improve current quality programs.
Documents, reviews, and approves incident reports, risk assessments, deviations, change controls, etc.
Reviews maintenance and inventory records.
Maintains incident reports, deviations, change controls, risk assessments, maintenance records, and inventory records.
Stays current on training and leads training as necessary.
Aids in the creation of SOPs.
Ensures all employees are compliant with cGMP regulations.
Performs internal audits.
Supports external audits.