Research Associate - QC

Job description

Integrity Bio, Inc. specializes in biologics formulation development and drug product manufacturing. We have formulated over 200 biologics including vaccines, antibodies, proteins, and peptides for more than 150 firms. Integrity Bio specializes in hard-to-formulate products in liquid and lyophilized forms.

We are located in Camarillo and Thousand Oaks California, the center of a highly concentrated cluster of 10,000 biotech professionals. Demand for our research services increased by 30% in the past year, driving continued expansion and need for great people.

We are seeking candidates for the position of Quality Control Associate


Major Responsibilities

Performs sampling and testing of samples from raw materials, in process, finished products, microbiology, and chemistry according to regulatory requirements.

Responsible for timely reporting and reviewing of results to internal and external customers.

Performs all work in compliance with company and FDA and international regulations. Maintains instrument readiness.

Recognizes test inconsistencies and takes appropriate corrective action.

Provides assistance to laboratory team members in resolution of similar problems.

Prepares buffers and solutions.

Calibrates/standardizes, maintains laboratory equipment. Troubleshoots and resolves instrument problems.

Authors SOPs, methods, and/or procedures. 

Identifies methodology problems, suggests improvements, and updates procedures.

May validate methods, procedures, and instruments.

Operates within a team-based environment. Participates in team activities.

Performs all activities in accordance with Good Manufacturing Practices.

Performs other miscellaneous duties as assigned.

 


Requirements

Strong interpersonal, written and oral communications skills
Ability to function efficiently and independently in a fast-paced, changing environment.

Must be able to multi-task effectively

Must be detail-oriented in all work activities.

Physical demand requirements: May require standing on feet up to 8 hours in a work shift. Must be able to wear required protective equipment.

Must be able to work overtime when required.

Must be able to work safely around chemicals and solvents.

 

Education 4 year degree in biology, chemistry, chemical engineering, or related field


Required Travel Up to 10%