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Title : AXG- Sample Management Specialist -244
State : Connecticut   Date : Jun 29, 2022
Experience Level :  
Position Type : Sample Management Specialist      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: New Haven, CT/ Boston, MA

Job Title: Sample Management Specialist

Duration: 18+ months (extendable) contract on W2


Position Summary:

This position will be involved in clinical and commercial stage biologics external manufacturing, internal and external (third party) testing, and data management supporting clinical manufacturing and process validation.  The Client’s RDU Product Development and Clinical Supply (PDCS) typically has four to eight manufacturing projects per calendar year, across clinical phases requiring sample management.

a. The Sample Management Specialist is responsible working with the team on defining the testing scope, developing the overall plan for requesting of samples, collection of samples during manufacturing, shipping, chain of custody, and compilation of data from testing.  
b. The specialist is responsible for effective planning through cross functional collaboration within the Client RDU Process Engineering and Process Validation, QA, Process Development, Formulation, Microbial Control, Q.C./A.S. protein characterization, stability and Clinical Manufacturing and Supply functions.  
c. Sample planning includes routine samples for release, non-routine for development, characterization, microbial control, and process validation.
d. The Specialist will be responsible for coordination and tracking of sample collection at manufacturing sites, internal to the Client, AstraZeneca, and Contract Manufacturing Organizations.  
e. The specialist will be responsible for planning and execution of shipping, via appropriate, contracted, controlled shipping organizations, with documented chain of custody, temperature log, and time stamp.  
f. The specialist will have responsibility for integral data collection in electronic, and certified means in support of GMP batch release, and process validation.
g. This role requires attention to detail, a high level of customer service, collaboration and cross functional support for Product Development and Clinical Supply and manufacturing operations.
h. The individual will serve as the link between process development, manufacturing, and Quality Assurance and deliver efficient sample management and data collection in GMP compliant manufacturing and quality systems.

Principal Responsibilities:

a. Actively partners with Process Engineering, Process Development, QC/ Analytical Sciences, Project Management, Clinical Manufacturing and Supply, external manufacturing, and Quality Assurance to ensure effective planning and execution of sample management (planning, shipping, testing and reporting
b. Author(s) and revise(s) technical documentation (e.g. sample plans, shipping plans and manifests, chain of custody, electronic and certified test results, etc.) as required
c. Integration of paper and electronic tools for sample management across the Client RDU PDCS, external manufacturing, external and internal testing laboratories
d. Responsible for QC test samples including receipt, storage, and distribution of samples to internal and external testing labs in accordance with required turnaround times
e. Maintains sample tracking and chain of custody records in accordance with cGMP and procedural requirements.
f. Requests, assembles, and distributes QC testing data for support of in-process, lot release, raw material
g. Maintains Quality Control testing source data and performs data archival as required.
h. Contributes to investigations and deviations related to QC sample management.
i. Responsible for alignment of manufacturing site raw material specifications and necessary in-house release testing requirements, in accordance with process raw material requirements.
j. Contributes to investigations and deviations related to QC raw materials.

Skills:

a. Excellent communication skills both written and verbal.
b. Effective time management, multitasking and organizational skills with the capability to manage multiple priorities concurrently.
c. Strong attention to detail and cross functional team experience.
d. Ability to work collaboratively to plan and execute independently.
e. Familiarity with cGMP and data integrity per Regulatory Agency expectations in bio pharmaceutical industry.  
f. Proficiency with computer systems such as Microsoft Office, divers Laboratory Information Management systems applications

Education: Bachelor of Science degree in Biological Sciences or related field.

Experience:

a. Minimum of 3 years of experience in the biotechnology or pharma industry with a primary focus on quality control laboratory analysis or sample management for regulated products
b. Experience with vendor management of CMOs and/or CTLs is preferred.
c. Experience with external manufacturing (CMO) and testing labs is preferred.
d. Familiarity with FDA,  ICH guidelines, USP/EP for raw material testing of pharmaceutical products is beneficial

Travel: Some domestic and international travel may be required, <10%.




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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com
NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
4390 US-1, Suite 110 
Princeton, NJ 08540
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