Company

KCR

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Quality Assurance Auditor (US)

City/voivodeship

Boston

Publication

2018-11-19

Company description

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries.
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A leading Clinical Research Organization (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ Quality Assurance Auditor. The new incumbent will be responsible for assessment of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of KCR projects, sites engaged, and vendors used to support clinical trials. The Quality Assurance Auditor will represent KCR while hosting external audits or inspections in the company’s Boston HUB.
Location: Boston (office-based/home-based)
The duties associated with the role include:
  • Performs internal and external audits: including audits of documentation, investigator sites, vendors following Yearly Quality Assurance Plan
  • Prepares audit reports
  • Acts as the company’s representative during external audits or inspections in KCR local HUB
  • Handles Quality Management System by preparation, update and review of Standard Operating Procedures (SOPs), policies and guidelines
  • Prepares and conducts external and internal ISO audits including: assistance with ISO re/certification, document verification, Quality Manual update
  • Assistance in Quality Assurance Plan preparation
  • Handles CAPA implementation in response to audits and inspection activities
  • Serves as a Subject Matter Expert for local policies, procedures and (FDA) regulations regarding clinical research operations
Requirements:
  • University/college degree
  • Excellent command of English
  • Prior relevant CRO experience in quality assurance area
  • Well-grounded knowledge of GCP, GMP, GLP regulations, ICH guidelines and clinical research process
  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and good working relationship with company personnel at all levels and with physicians and scientists from various disciplines
  • Sound judgement to evaluate discrepancies, make decisions and report findings
  • Deep understanding of processes in various areas of clinical project execution, ability to identify gap in the process and ability to provide alternative solutions to cover the process gaps, ability to handle confidential information diplomatically
  • Proficiency with computing software
  • Ability to manage work schedule in accordance with priorities
  • Ability to travel across the US/DE to perform QA responsibilities

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits
that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with: 
  •  3-step onboarding process to enable you fast takeover of duties
  •  Peer Buddy Mentor who will introduce you to the organization
  •  Friendly office space, coffee, tea and sweets
  •  Flexible, remote working options
  •  Time off – additional days of holidays for birthday, leaves of absence
  •  Loyalty bonus for long term cooperation
  •  Employee referral program
  •  Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  •  Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
  •  Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
 
If you wish to apply, please submit your CV using the button below.