CenterWatch

Keep the discussion going--join our JobWatch Group on LinkedIn!

Sign In
 [New User? Sign Up]
Mobile Version

SE51 - Quality Assurance Associate

Kelly Services


Location:
Fort Collins, CO
Date:
04/19/2018
2018-04-192018-05-19
Job Code:
US15TPCS_BH1421902
Kelly Services
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Job Title SE51 - Quality Assurance Associate

Jobid US15TPCS_BH1421902

Location: Fort Collins, CO, 80528, USA

Description **Quality Assurance Associate - 12 month contract position (located in Fort Collins, Colorado)**

This positon supports R&D Projects and Programs that are in development through Phase IV clinical trials by providing guidance based on relevant regulations and internal processes and procedures

Review of CMC program protocols/development reports and provide timely builds to R&D QA Manger and appropriate Project lead

This positon provides back-up support for R&D QA Manager for SOP and relevant document approvals, as required

Identification of high risk areas and provide recommendations on remedial actions that may impact product development

Evaluate, challenge and contribute to enhancements in the R&D Quality Management System

Provide guidance and input on appropriate corrective actions to ensure continuous improvements in the process capabilities

Conduct pre-assessments of suppliers, Contract Manufacturing Organizations, and vendors involved in the manufacture, testing and packaging by or on behalf of the company to assess compliance to proposed protocols, regulatory requirements and effectiveness of their quality systems

Lead or participate in internal audits involving R&D CMC and Regulatory systems

Ensure timely issuance of reports, evaluate and track audit Reponses

Prepare technical/quality agreements for review and approval by management

Develop QA plans based on risk assessments in support of development projects

Ensure appropriate drug supply points are suitably assessed for clinical trials including phase I-IV and investigator intimated trials

Support CMC and associated other R&D functions in process mapping/improvement to ensure cross functional processes are detailed appropriately

Use Risk Assessment and Problem-Solving techniques to improve quality

Participate in regulatory inspections of GMP systems as a QA representative, as required

Participate in regulatory inspections of GMP systems as a QA representative, as required

Lead site mock inspections, as required

**Education/Experience:**

Bachelor of Science Degree

Master of Science

Strong working knowledge of US and EU Good Manufacturing Practices and Medical Devices required. GLP knowledge a plus

**Must possess a proven track record (3 years)** in regulated industry such as FDA, Pharma organizations, medical device or CMO, with concentration in at least one for the following functions: aseptic manufacture, analytical testing, lyophilization or sterilization.

Demonstrated knowledge of drug development


**Why Kelly** **®** **?**


The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
**AboutKelly Services** **®**


As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm



Powered ByLogo