Formed in 2002 out of a need for high-caliber consultants within the life sciences industry. Sequence, Inc. is well-known in regulated industries as a validation and engineering services provider, specializing in quality and compliance services for software, IT infrastructure, laboratory instruments, analytical methods, equipment, automation, processes, cleaning and utilities, as well as process optimization, laboratory software support, remediation, regulatory compliance services, system/facility startup and much more. All of our work is done in-house with oversight from a management team that cut its teeth in regulatory compliance.

We are currently looking for a Quality Management Systems Professional (Consultant level) to support our needs in the Raleigh area. Candidates will need experience creating, improving, and/or revising Quality Management Systems (QMS). Candidates with a willingness to travel at a minimum of 25% or more both in-state and out-of-state will be given top priority. 

Essential Functions and Responsibilities

  • Daily management of project activities and deliverables
  • Providing Regulatory Guidance and Quality Assurance regarding compliance with an intended specification
  • Test Execution and Deviation Management
  • Planning and scheduling of deliverables

Minimum Requirements

  • 2+ years of applicable work experience in the biotechnology industry
  • 2+ years of experience optimizing Quality Management Systems
  • Knowledge in one or more QMS
  • Experience in change controls, CAPA (Corrective Action/Preventative Action), maintenance, calibration, validation, auditing, and Quality Control (QC) testing
  • Ability to develop and manage client relationships while identifying new opportunities
  • Knowledge and utilization of regulatory compliance standards and quality assurance within regulated industries, with the ability to understand the clients' business and offer impactful solutions fit to their needs
  • Exceptional communication and organizational skills
  • Willingness to update and maintain knowledge by participating in educational opportunities and maintaining personal networks

Preferred Experience (Not Required)

  • Understanding of the Validation Lifecycle (GAMP 5)
  • Understanding of business processes as applicable to computerized systems
  • Understanding of GxP, GAMP, CFR’s as they relate to validation
  • Understanding of how to apply SOPs, work instructions, and regulatory requirements to the validation of computerized systems
  • Understanding of Agile methodology
  • Understanding of Data Integrity concepts
  • Understanding of Cloud Computing
  • Knowledge of GxP, GAMP, CFR’s (Part 11)
  • Experience with electronic testing tools such as HP ALM
  • Documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures

Our consultants must be knowledgeable and willing to go the extra mile in service of a client, your success is our success. Here are some of the Benefits we offer:

  • Competitive Pay
  • Medical, Dental, and Vision Insurance
  • 401k plan with employer contributions
  • Generous PTO/ Time off
  • Bonus Plan
  • Reimbursable Expenses (Phone, Internet, and Mileage to Client Site)

We value our employees, and beyond the great pay and benefits we offer, we care most about offering opportunity. We are a rapidly growing consulting firm and would love to discuss the prospect of you joining our team. Sequence Inc. is proud to be an Equal Opportunity Employer, M/V/D/F. You will be considered for this position based upon your experience, without regard to race, color, religion, sex, national origin, age, sexual orientation, ancestry; marital, disabled or veteran status. Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Sequence.

Candidates who are currently employed by a client of Sequence or an affiliated Sequence business may not be eligible for consideration.

 

Equal Opportunity Employer, including disabled and veterans.

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