HI,

Hope you are doing great!

This is Harry from Dynamic Enterprise Solutions. We have urgent requirement
with one of our client's, please review below job description and let me
know your interest

 

Position ID: DYES00007875

Title: Quality Assurance (QA) Project Coordinator 

Location: Worcester, Massachusetts
Duration: 12 Months+

 

Locals Only (phone and onsite interviews only)



Description:
Project Coordinator II, Quality Control Services will be responsible for
overseeing of outsourced analytical GMP activities (CTLs) for late phase
clinical and commercial programs from initial feasibility through method
qualification, and routine release and stability testing. 

Summary Of Key Responsibilities 

*       Technical and program management support of outsourced GMP/GxP
release and stability programs. 
*       Oversight of analytical technology transfer and feasibility, method
validation, and routine release and stability testing at CTL vendors. 
*       Review of release and stability testing data. 
*       Supports the coordination with Quality and Program Managers to
provide project updates, workflows, and timelines. 
*       Author technical documentation (e.g. SOPs) with appropriate level of
guidance, as needed. 
*       Can make presentations on validation and release/stability
activities. 



Qualifications 

*       3+ years of experience in Quality Control / GMP laboratories is
required. 
*       Experience with vendor management of CTLs is preferred. 
*       Excellent team skills, organization, and strong. 



1.      What are the top 5 skills/requirements this person is required have?


a.      a. Required Skill 1: QC/ GMP background 
b.      b. Required Skill 2: Experience working in QC Analytical lab
performing method validation, release and stability testing 
c.      c. Required Skill 3: Program Management support 

2.      What years of experience, education, and/or certification is
required? 

a.      BS/MS; 3+ years of experience in Quality Control / GMP laboratories
is required. 

3.      What is a nice to have (but not required) regarding skills,
requirements, experience, education, or certification? 

a.      Experience with vendor management of CTLs is preferred 

 

 Thanks & Regards 

Harry John
Business Development Manager
Dynamic Enterprise Solutions Inc 

1801 Hicks Rd, unit A

Rolling Meadows, IL -60008

(847) 719-7902 / (847) 874-7274
C 224-635-0898

Email:  <mailto:ha...@dynamic-enterprise.net> ha...@dynamic-enterprise.net

URL: http//  <http://www.dynamic-enterprise.net> www.dynamic-enterprise.net

 

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