Job: Associate Mfg

Jobing Description

This is a 4th Shift Opportunity (7am-7pm Sat, Sun & Mon.)
Under general supervision, employee will perform operations in the Purification area. Operations will be performed according to Standard Operating Procedures (SOPs). Employee will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Employee may perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams. Employee may also have the responsibility of owning NC/CAPA s. May identify, recommend, and implement improvements related to routine functions Basic Qualifications ? Bachelor s degree
OR
Associate s degree & 4 years of directly related experience
OR
? High school diploma / GED & 6 years of directly related experience
Preferred Qualifications - Knowledge of Purification operations
- Knowledge of WIP lab equipment and computers.
- CFR and Regulatory knowledge
- Mechanical ability/expertise
- Basic statistical mathematical skills
- Ability to interpret and apply GMP knowledge
- Understanding of analytical methods for manufacturing area
- Ability to demonstrate technical writing capability with Trackwise access
- 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.