Manufacturing Associate
Astrix Technology
**Manufacturing Associate**
Manufacturing
Morrisville, NC, US
Pay Rate Low: 20 | Pay Rate High: 23
+ Added - 11/12/2024
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**_Our client, a leader in biotechnology, is looking for a Manufacturing Associate to join their growing team!_**
**Pay:** $20-23/hr
**Location:** Morrisville, NC
**Job Type:** Contract
**Key Responsibilities:**
+ Use of MBRs and SOPs to produce clinical material from cell expansion through downstream processing in non-GMP and GMP settings.
+ Prepare support solutions, pack and qualify chromatography columns, perform post-use operations.
+ Set up and maintain analytical instruments in the manufacturing area.
+ Edit and revise Standard Operating Procedures (SOPs) and logbooks for equipment setup and operation.
+ Liaise with the supply chain department for raw material delivery to manufacturing and raw material cleaning and stocking into manufacturing suite.
+ Perform waste decontamination and removal in partnership with EHS.
+ Enter batch production data into databases and perform documentation reviews.
+ Maintain quality standards to meet cGMP requirements and complete documentation utilizing GDPs, CFRs, and internal company policies directly related to the manufacturing process as required.
+ Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
**Education/Experience:**
+ A.S degree, Biomanufacturing certification, or equivalent industry experience.
+ B.S. degree (preferred) in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
+ Working knowledge of FDA regulations and GMP system.
+ Previous cGMP batch documentation authoring and lifecycle management experience.
+ 2 years of experience in biologics based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish.
\#INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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