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22 days old

Quality Complaint Specialist

Kelly Services
PA
Kelly Project Services, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking Remote **Quality Complaint Specialists** for a long-term engagement at one of our Global clients in Spring House, PA.


This role is a full-time, fully benefitted position. As a Kelly Project Services employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly Project Services employees receive annual performance reviews.


As a Quality Complaint Specialist placed with Kelly Project Services you will be responsible for the following: Bioresearch Quality & Compliance (BRQC) / Quality Planning & Strategy


**Position Summary:**

Quality Specialist will support the creation, monitoring, effectiveness, and closure of self-identified Quality Issues (QIs) &/or Significant Quality Issues (SQIs) for Customer R&D (e.g. Therapeutic Areas (TA), Bioresearch Quality & Compliance (BRQC) etc.).

Under the management of the Director, Risk Management Compliance this person is responsible to assist and support processes related to self-identified quality issues to ensure that quality events identified are robustly investigated, corrected, and documented in the Customer event tracking system in accordance with standard operating procedures as well as escalated to senior management when appropriate.


**Responsibilities** : Main responsibilities will include, but are not limited to:

Collaborate with key stakeholders to support the process for self-identified management of quality issues and action plans identified which includes but is not limited to:

Assessment of quality issues identified by R&D Business Partners and BRQC customer colleagues to determine if further investigation (including root cause analysis if applicable) is needed.

Review QI Impact Assessments in a timely fashion after QI entry to determine need for TrackWise/REACT entry/ Escalation to senior management. Enter TrackWise /REACT records when necessary.

Collaborate with QP&S Therapeutic Area Head and/or Escalation Lead to develop complete and accurate REACT entries to facilitate decision-making.

Completion of records (including coordination of evidence) to document the outcome of investigations in TrackWise / REACT system.

Monitor progression, track, and trend significant quality issues /(SQI) to ensure records are processed in a timely fashion; communicate due dates for QIs, SQIs, CAPA, etc. to ensure on time completion.

Escalate individual SQI records at risk for going overdue and/or negative trends in Key Performance Indicators to the appropriate forums and management

Must be able to work independently and coordinate across the Quality organization to progress quality investigations to ensure compliance to SOP timelines.

Must have a firm understanding of the issue management process to engage key stakeholders to assure on time processing and completion of significant quality issues.


**Knowledge, Education, Experience skill requirements:**

Bachelor of Science (BSc) degree in a life science, natural science or business is preferred with a minimum of 5 or more years of previous Pharmaceutical Industry experience

At least 2-3 years experience in an applicable compliance field and/or the equivalent time and training/experience in a related R&D area (GxP regulated discipline)

Excellent organizational, analytical, strategic, interpersonal, written, and oral communication skills are required.

Knowledge of the global drug development process, including current functional GxP compliance regulations

Proficient in Microsoft Office and TrackWise application experience required

Experience working with multidisciplinary and cross functional leaders from R&D, Medical Safety, Regulatory and Quality functions

Strong personal leadership with demonstrated competency interfacing with management, strong networking, and relationship-building skills are required

Experience in synthesizing information and providing key insights to promote quality objectives.

Strong analytical skills & experience with implementation of new concepts

Strong written, visual, verbal communications with peers, business partners & senior management

Ability to analyze and interpret data, derive insights, and determine root cause to adjudicate issues in the research and development process

Disciplined approach to defining and addressing problems

Strong blend of both strategic and tactical approaches to quality and business objectives

Knowledge of quality and risk management terminology and proficient knowledge of scientific terminology

Self-motivated and flexible with the ability to work effectively in a dynamic, fast-paced, problem-solving environment is required.

Demonstrated strength in influencing and negotiation skills and ability to communicate effectively with higher levels of the organization is required.

Ability to drive change and to perform in a team and matrix organization, as well as adapt to a dynamic environment is required.

Demonstrated competencies required include industriousness, self-awareness, adaptability, attention to detail, and a high capacity for teamwork.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-31 Expires: 2021-05-15

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Quality Complaint Specialist

Kelly Services
PA

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