Site Quality Associate

Site Quality Associate

Job Location: US-NV, Las Vegas

Position Type: Regular Full-time, On-Site


Reports to: Site Quality Manager

About Metro Logics, Inc.

Metro Logics, Inc. (Metro) is a privately owned medical logistics service company located in Las Vegas, NV, with additional facilities in Mississippi and Utah. We provide temperature-sensitive storage, warehousing, and rapid distribution services for perishable foods, pharmaceutical products, and medical devices and supplies. Metro manages highly regulated, temperature-controlled, and cGMP-compliant warehouse space.

Overview

Job specifications are intended to present a descriptive list of the range of duties performed by employees. Specifications are not intended to reflect all duties performed within the job.

About the role

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.


Essential Duties and 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.

Qualifications and Relevant Experience

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

Skills

• Leads by example and drives organizational performance and continuous improvement.
• Comprehensive understanding of quality systems, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other governmental regulations.
• Ability to connect and build strong relationships with others, while fostering a positive work environment.
• Must be able to work efficiently and effectively and remain self-motivated.
• Ability to effectively share knowledge with others within the organization.
• 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.

Physical Demands

• Regularly required to stand, walk, sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs, balance, stoop, kneel, crouch or crawl, talk or hear.
• Must occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to focus.

Additional Qualifying Factors

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.


Metro is an Equal Employment Opportunity Employer as to all protected groups, including protected veterans and individuals with disabilities.

NOTICE TO THIRD-PARTY AGENCIES:

Metro Logics, Inc. is only accepting direct applicants; third-party recruiters, employment agencies, and/or other staffing services will not be considered.