Sr. Quality Assurance Consultant

1 week ago

Chesapeake Beach, MD, United States Quality Agents Full time
Overview

Quality Agents, LLC is a service company that offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Senior Quality Assurance Consultants are leading service providers to our clients providing GMP support. The individual will coordinate Quality Assurance activities with the client and meet timelines.

Responsibilities
  • Provides high level resolution of root cause and corrective action items
  • Develops quality systems/procedures and provides QA guidance
  • Contributes to the QA planning and risk assessment activities
  • Leads or co-audits vendors, internal and external systems
  • Conducts investigations of GMP related issues and creates corrective action plans
  • Reviews Environmental monitoring and additional QC data
  • Interprets regulatory authority regulations and guidelines to verify compliance
  • Administers and maintains various Quality Management Systems, including: change management, deviation management, document control, records management, and GXP training management
  • Complies with all applicable policies regarding health, safety, and environmental policies
Skill Level and Requirements
  • Ability to problem solve and troubleshoot.
  • Technical writing ability and use of Microsoft Word, Excel, Power point, and Project
  • Customer service experience in a scientific field is desired.
  • BS in a technical discipline (Engineering, chemistry, microbiology, biology)
  • Energetic, results-driven with excellent organizational and prioritization skills
  • Excellent written and verbal communication skills
Minimum Requirements
  • BS in a technical discipline (Engineering, chemistry, microbiology, biology)
  • 5-10 years of experience in at least one of the following areas: Quality Assurance, equipment/utility qualifications, process validation, analytical method validation, or cleaning validation.
  • Current drivers license and auto insurance
Benefits
  • Health, dental and vision insurance
  • Life, AD&D and disability Insurance
  • Health savings account for participants in our health plan
  • 401k retirement plan
  • Paid vacation
  • Paid sick leave
  • Paid holidays

Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.

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