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Specialist Quality Assurance #26-16048

US Tech Solutions, Inc.

Louisville, KY

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JOB DETAILS
SKILLS
Academic Background, Biology, Biotech and Pharmaceutical, Business Operations, Change Control, Change Management, Communication Skills, Cross-Functional, Detail Oriented, Distribution Warehousing, Diversity, Documentation, Documentation Review, Drug Products, ERP (Enterprise Resource Planning), External Audit, GMP (Good Manufacturing Practices), High School Diploma, Import/Export, Industry Standards, Internal Audit, Laboratory Information Management System (LIMS), Leadership, Manufacturing, Manufacturing Technology, Materials Analysis, Metrics, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Multitasking, Physical Science, Problem Solving Skills, Project Tracking, Quality Assurance, Regulations, Risk, Risk Analysis, Risk Management, Sampling Inspection, Staff Training, Standards Development, Warehousing
LOCATION
Louisville, KY
POSTED
4 days ago
Duration: 18 months contract

Job Description:
  • The ideal candidate will have 5+ years of QA experience specifically involving raw materials in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries. A bachelor’s degree is strongly preferred; master’s candidates may be considered, but Ph.D.-level talent may be too senior for the scope. This role is physically active and requires passing an eye exam, lifting materials (~40 lbs), and consistent gowning (jumpsuit, scrubs, goggles). While officially remote (per internal classification), the worker must be onsite daily. Candidates must be local or self-relocate, no exceptions. Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential. Avoid candidates seeking remote-only work or lacking QA/GMP/raw material background.
 Responsibilities:
  • Ensure that all operations comply with relevant regulations and requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
  • Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
  • Compile and review documentation associated with receipt, storage, incoming inspection, and distribution
  • Perform routine Quality Assurance assessments and provide direct operational oversight
  • Provide expert advice on quality matters to operational teams and cross-functional groups
  • Ensure staff complete necessary training related to business operations
  • Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
  • Achieve established metric targets and develop standardized approaches for tracking progress
  • Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
  • Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
  • Support internal and external audits and inspections as a member of the audit/inspection team
  • Perform additional duties as assigned by management
 Preferred Qualifications:
  • Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
  • Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
  • Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
  • Expertise in managing deviations, change controls, and CAPAs
  • Proficiency in Veeva, SM LIMS, and ERP systems
  • Knowledge of industry standards (GMP, GDP, Import/Export)
  • Commitment to exemplifying core values
  • Demonstrated self-leadership and motivation
  • Strong strategic thinking skills
  • Ability to evaluate compliance issues and engage with regulatory inspectors
  • Experience managing multiple priorities within a dynamic environment
  • Direct experience with drug substances and/or drug products
  • Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
  • Track record of representing an organization during regulatory interactions
  • High proficiency in Microsoft Excel, Word, and PowerPoint
 Basic Qualifications:
  • Doctorate degree OR
  • Master’s degree and 3 years of experience OR
  • Bachelor’s degree and 5 years of experience OR
  • Associate degree and 10 years of experience OR
  • High school diploma / GED and 12 years of experience
 Top 3 Must Have Skill Sets:
  • Warehousing
  • Raw material incoming inspection and sampling
  • Raw material disposition
 Day to Day Responsibilities:
  • Warehouse and Raw material incoming inspection and sampling oversight and Raw material disposition
 
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
 
US Tech Solutions is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
 
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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About the Company

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US Tech Solutions, Inc.