Quality Assurance Associate (Mahwah)

PRA Health Sciences in Mahwah, NJ

  • Industry: Information Technology - Software Quality Assurance Analyst
  • Type: Full Time
Apply for this job

Overview



Do you want to be responsible for performing review, coding, and entry of audit report findings, assists with facilitation of Corrective and Preventative Actions (CAPAs), and participates in GCP related projects? Participates in facilitating or co-audits as experience increases and proficiency is demonstrated.

Who are we?

We Are PRA.

We are 18,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

Who Are You?

You are an experience professional with a passion for clinical supplies. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your project teams, but also to clients. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. Most of all, you want to do it in a place where you re more than an employee number. A place you love working.

Still here? Good. Because if this is you, we d really like to meet you.

Responsibilities



What Will you Be Doing?
  • This individual will be expected to support the review and revision of Quality Agreements with our clinical contractors who perform a diverse set of services for Merck in laboratory, manufacturing, packaging and distribution spaces. This may also include supply relationships with commercial sites.
  • This requires an individual with strong communication skills, ability to understand complex supply chains and ability to quickly develop organizational awareness/savvy.
  • Additionally this individual will support as capacity permits: maintenance activities associated with our electronic supplier management systems. CAPA verification activities for commitments post audit Administrative functions associated with the audit request and schedule process
  • Applies knowledge of ICH GCP to interpret audit findings and conduct peer reviews (as appropriate)
  • Generates initial response to general ICH GCP questions
  • Facilitates tracking of escalated issues to resolution
  • Communicates with multiple levels within the organization
  • Supports implementation of revised processes and procedures

Qualifications



Education and Work Experience:
  • An undergraduate degree or its international equivalent from an accredited institution preferred.
  • Preferably in the health-sciences or computer sciences
Knowledge, Skills, and Abilities:
  • Experience in clinical research organization is preferred
  • Basic understanding of ICH GCP, FDA CFR, and EU directive
  • Read, write and speak fluent English; fluent in host country language required.
  • Working knowledge of the Clinical Trial Supply process
  • Working knowledge of project team structure and processes
  • Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
  • Knowledge of project management and Clinical customer relationship building
  • Knowledge of the Customers team structures and processes
  • Excellent verbal and written communication skills
  • Ability to influence others
  • Ability to multi-tasks
  • Strong organizational skills
  • Experience in conflict resolution and negotiation skills
  • Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project and Access
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Associated topics: automation, process, prevent, quality assurance, quality assurance engineer, software quality, software quality assurance, software quality engineer, software quality assurance engineer, tester
Apply for this job

You may be interested in these similar jobs!
Program Associate
L Marks in New York, NY

Program Associate - Intrapreneurship L Marks is working to transform corporate businesses by promoting the ideas of their entrepreneurial employees. …

Read More
General Restaurant Manager – Grab & Go Concept!
CoRecruitment in New York City , NY

General Restaurant Manager – Grab & Go Concept! Salary: Ranging from $55K - $72K + 30% Yearly Salary Bonus and much much more! Location: NYC, N…

Read More
Youth Sales Representative
Riddell in Long Island, NY

Youth Sales RepresentativeRiddell is a premier designer and developer of football helmets, protective sports equipment, head impact monitoring techno…

Read More
Life Insurance Agents 100% remote, all inbound qualified leads (Port Chester,NY)
ASSURANCE Independent Agents in Port Chester, NY

Join the revolutionary ASSURANCE platform, and enjoy the freedom of working when you want, from wherever you want, helping inbound, qualified, in-mar…

Read More
Quality Assurance Associate (Clifton)
PRA Health Sciences in Clifton, NJ

OverviewDo you want to be responsible for performing review, coding, and entry of audit report findings, assists with facilitation of Corrective and …

Read More
Operator (Wayne)
Sika in Wayne, NJ

Operator New Jersey United States of America Exciting Challenges Responsible for the operation of a manufacturing and/or packaging line(s),…

Read More
QA QC Specialist (Newark)
Staffing the Universe in Newark, NJ

Quality Control Temp will utilize procedures and techniques in performing a broad range of duties related to the routine activities of analytical ope…

Read More
iT Associate
Innovation labs in New York, NY

IT ASSOCIATELocation: iLABS, Mahwah, NJEmail Resume to: ...@ilabsus.com Innovation Labs (iLabs) is an innovative skincare / cosmetic research & manuf…

Read More
Retail Sales Associate, Key Holder (Union City)
Destination XL in Union City, NJ

DXL Group, the largest specialty retailer of men's XL apparel, is looking for a Retail Sales Associate, Key Holder who is committed to building long …

Read More
Production Investigation Specialist (Westwood)
Akorn in Westwood, NJ

SUMMARY: By using Root Cause analysis training and process improvement skills, assist operations management in evaluation to improve the producti…

Read More
Production Associate II (North Bergen)
Select Source International in North Bergen, NJ

Job Description Machines, Tools, Equipment (Office and Industrial), Software Used: 1. Portable radiation survey and safety instrumentation. …

Read More
Entry-level Software Development Role - Manhattan (Woodside)
Year Up in Woodside, NY

Are you interested in an entry-level software development? Year Up is a one-year, intensive program that provides young adults with hands-on skill de…

Read More
Software Development Internship Program - Manhattan (East Elmhurst)
Year Up in East Elmhurst, NY

Are you interested in an entry-level software development? Year Up is a one-year, intensive program that provides young adults with hands-on skill de…

Read More