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Title : SQG- QC Specialist-Reference Standards Coordinator -091
State : North Carolina   Date : Jan 21, 2022
Experience Level :  
Position Type : QC Specialist-Reference Standards Coordinator      
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: Holly Springs, NC  

Job Title: QC Specialist-Reference Standards Coordinator

Duration: 12+ months (extendable) contract on W2


The reference standards coordinator is responsible for the qualification and management of SRD antigen reference standards used in the SRD analytical method within the broader QC organization.  The QC Specialist is responsible to coordinate with the relevant portions of the business to identify the actions required and support the tracking of key dates and delivery of SRD reagents while ensuring all work adheres to cGMP and regulatory regulations. This role requires technical ability to evaluate qualification results and appropriately document results in a technical report.  This role reports into the Head of Global Analytical Services and is cross-functional with stakeholders in QC and Analytical Services & Technology (AS&T).

Responsibilities:

a. Manage the completion of SRD reference antigen standard generation, including tracking of schedule, and proposing/supporting process improvements
b. Author and review technical reports to support qualification of reference standards and controls.
c. Coordinate qualification testing, in collaboration with QC laboratory operations and AS&T/TD groups
d. Trend data using appropriate statistical analyses.
e. Coordinate shipment and distribution of SRD antigen reference standards and reference materials to users, such as QC Operations and product release testing laboratories (i.e. OMCLs)
f. Identifies and implement solutions to technical problems related to the development of reference standards and the analysis of data, including reviewing deviation events and failure investigations and providing technical input for OOS and OOT investigations.
g. Perform other duties as assigned.

Qualifications:

a. Degree in related scientific discipline (natural, pharmaceutical, medical, archival or information technology) with a minimum of 5-7 years of laboratory experience in a GMP regulated Biologics or Pharmaceutical environment
b. Strong knowledge of biochemistry and molecular biology, specifically familiarity with execution in and analysis of data generated from total protein, SDS-PAGE, and immunodiffusion analytical methods.
c. Understanding of basic statistical applications, i.e. control trending, JMP, excel, etc.
d. Prior knowledge of working with and/or qualifying reference standards is preferred
e. Strong technical writing skills with proven experience in the preparation of SOPs, work instructions, qualification protocols and reports
f. Ability to operate independently where appropriate to prioritize tasks and manage multiple projects yet understand when to escalate issues
g. Ability to handle multiple projects in a fast-paced and high-volume dynamic environment
h. Ability to work collaboratively with other functions
i. Strong problem-solving skills with demonstrated attention to detail



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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