Company

KCR

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Quality Assurance & Compliance Specialist | US

Publication

2021-09-15

Company description

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.comWe see human behind every number.

 

Quality Assurance & Compliance Specialist

 

Location: United States (home-based)

 

Scope of responsibilities:

 

The Quality Assurance and Compliance (QA&C) Specialist is a part of the global Quality Assurance and Compliance organization, and may serve as:

  • liaison for ISO and client audits of KCR,

  • auditor or co-auditor for internal and external audits,

  • expert in SOP creation and modification,

  • manager of quality metrics and data,

  • support in regulatory inspections,

  • QA&C resource to project teams.

All of the above are conducted under the explicit assignment by and direction of the Head of QA&C Department.

 

The QA&C Specialist develops and implements KCR’s centrally managed, ISO-certified Quality Management System (QMS), assures corporate alignment and compliance with all pertinent regulations and laws including ICH-GCP, 21 CFR 11 regulations, EU Directives, ISO 9001-2015 standards, Data Privacy requirements as well as internal policies, procedures, and SOPs to manage and maintain regulatory compliance and the successful conduct of clinical research activities.

 

Qualifications:

  • University/college degree (life science or medical degree) preferred and/or experience as deemed relevant by the Head of QA&C Department;

  • At least 2 years of experience in a supporting or active quality-ensuring function in a CRO, pharmaceutical, medical device, biologic and or biotech environment that is subject to clinical research regulations and guidelines;

  • Strong knowledge of the clinical trial process, ICH-GCP Guidelines, regional regulations and guidelines as the pertain to clinical research and ISO 9001-2015 standards. GLP, GMP, EDC and e-Clinical knowledge is recommended;

  • Excellent professional level written and oral communication in English;

  • Good professional image with experience working with various levels of personnel, particularly senior management and outside clients.

At KCR, we put our mission: we see human behind every number into our actions, therefore we offer Our Employees benefits that are being reviewed on a regular basis and to comply with national regulations and to ensure that we provide the coverage that best meets employee needs.

To show that you are appreciated in our team, prove our appreciation, while working at KCR you will be provided all employees with the following:

  • Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;

  • Efficient Onboarding process to enable you fast takeover of duties;

  • Peer/ Buddy/ Mentor who will introduce you to the organization;

  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;

  • Empowering workspace, offering opportunities to share ideas and influence company services development worldwide;

  • Mentoring and training programs related with in clinical trials, therapeutic areas, soft skills development;

  • Additional days-off for certain special occasions.