Production Associate I-Collagen

Role Summary

The Production Associate I - Collagen performs activities involved in the production of Collagen, including protein purifications, filtrations, and titrations to produce high quality, purified, sterile collagen for internal and external customers. This position operates in a regulated area under the direct supervision of a team leader or departmental supervisor.

Responsibilities

• Responsible for producing collagen by performing protein extraction and purification, filtrations and dilutions, and chemical sterilizations following cGMPs
• Responsible for performing in process testing including assays, titrations, and other color indicator testing
• Responsible for running specialized equipment including a continuous flow centrifuge
• Responsible for cleaning and assembling glassware and equipment for sterilization
• Responsible for completing production documentation in a timely manner
• Responsible for performing all tasks in compliance with company safety policies especially involving chemical safety and proper lifting techniques
• Provide assistance with process optimization and scale-up activities, if necessary
• May provide assistance to Engineering and Facilities Departments, as necessary, for equipment operation during calibration, validation, or repair
• Maintain laboratory inventory supply
• Responsible for writing of deviation reports, as necessary

Qualifications

• Required: B.S. or A.S. in a biological science or equivalent and 0-2 years of relevant experience
• Preferred: Quality Systems regulations (cGMP) knowledge and clean room experience
• Required: Knowledge of basic laboratory techniques and equipment such as using pipets and balances
• Required: Physical ability to lift and push/pull as per safety requirements and good dexterity
• Required: Ability to work in cold room conditions (2-8°C)
• Required: Ability to closely follow procedures and strong attention to detail
• Required: Good written and verbal communication skills
• Required: Good problem solving skills

Education

• B.S. or A.S. in a biological science or equivalent

Physical Demands

• A pre-employment physical and lift test is required for this role
• Ability to work in a cleanroom environment for extended periods
• Must have the ability to work in cold room conditions (2-8°C)
• Must have the ability to lift up to 50 pounds