Overview
BioManufacturing Investigator II – Minor Deviations Jobs in Durham, North Carolina, USA at Randstad Enterprise
Bio Manufacturing Investigator II – Minor Deviations
Randstad Enterprise is seeking an experienced Biomanufacturing Investigator to join the team. The Investigator II will support large-scale manufacturing to ensure thorough investigations and resolutions. The role involves cross-functional collaboration for positive outcomes and the implementation of solutions and CAPAs to optimize operations.
This is a temp-to-perm contract position with excellent opportunity for conversion. It is 100% onsite in Durham (RTP), Monday to Friday, 8 am to 5 pm.
Main Responsibilities:
Conduct thorough investigations of deviations and identify appropriate corrective actions.
Conduct interviews and collect data to determine root causes.
Write technical investigation reports, documenting findings and actions in compliance with requirements and safety regulations.
Qualifications:
Strong understanding of root cause investigation and analysis.
Knowledge of manufacturing processes and equipment, preferably in large-scale molecule production.
Familiarity with current regulations and cGMP standards.
Knowledge of aseptic filling processes.
Experience with enterprise systems such as Track Wise.
Experience with systematic cause analysis methods (e.g., event & causal factor charting, fault tree analysis).
Ability to synthesize information from multiple SMEs into clear and concise reports.
Education and Experience:
3 years of experience with a Bachelor’s degree.
5 years of experience with an Associate’s degree.
Additional Details:
Seniority level:
Associate
Employment type:
Contract
Job functions:
Manufacturing and Quality Assurance
Industries:
Biotechnology Research and Pharmaceutical Manufacturing
Benefits include medical insurance, vision insurance, and 401(k).
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Title: BioManufacturing Investigator II – Minor Deviations
Company: Randstad Enterprise
Location: Durham, North Carolina, USA
Category: Quality Assurance – QA/QC (Quality Engineering)
