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Role Summary
Associate Manufacturing Nights
Responsibilities
Perform and monitor critical processes, complete routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
Perform basic troubleshooting and assist in the review of documentation for assigned functions.
Participate on cross-functional teams and represent Manufacturing.
May also have the responsibility of owning NC/CAPA’s.
May identify, recommend, and implement improvements related to routine functions.
Qualifications
Basic Qualifications:
High school/GED + 2 years of manufacturing or operations work experience OR
Associate’s + 6 months of manufacturing or operations work experience OR
Bachelor’s degree
Preferred Qualifications:
Knowledge of single-use Bio-manufacturing technology
CFR and Regulatory knowledge
Mechanical ability/expertise
Knowledge of lab equipment and computers
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to demonstrate technical writing capability
Able to demonstrate project management skills and presentation skills
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Basic troubleshooting skills
Experience with Delta V, RD’s
Experience with lab equipment/testing
Skills
Manufacturing operations
Documentation and technical writing
Troubleshooting
Cross-functional collaboration
Process validation
Education
High school diploma or equivalent; Associate’s or Bachelor’s degree as alternatives in Basic Qualifications