Job Description Overview:
- THIS IS A FULL TIME/DIRECT HIRE POSITION LOCATED IN GAINESVILLE, FL
The QC Engineer assists with maintaining the Quality Control Systems with the organization including but not limited to maintaining the validation program, maintaining change control process, development and execution of design control and ensuring compliance to AATB Standards, FDA Regulations and relevant state/local laws for the biotechnology industry.
- Controls and maintains the quality system to meet all applicable regulatory requirements
- Develop, implement and document the qualification, verification and/or validation of significant components of the facility, processes, equipment, reagents, labels, containers and packaging materials
- Manage projects for quality improvement and process optimization including effectiveness checks for efficiency
- Manage the Change Control Process
- Responsible for writing and/or assisting in the writing of SOPs and Work Instructions
- Assist in Design Control Process and manage design transfer for new products
- Responsible for maintenance of environmental monitoring
- Train QC Inspectors on inspection techniques and the use of new equipment
- Assist in internal and external audits as directed
- Maintain and report quality control data for management team
- Act as liaison between Operations and Quality Assurance
- B.A. in Engineering or five years experience in Quality Control, Regulatory Affairs or other FDA Regulated industry experience.
- CTBS or ASQ certification is preferred
- Ability to read, analyze, interpret and apply AATB Standards, FDA Regulations, Standard Operating Procedures (SOP) and Policies
- Must be able to calculate fractions, percentages and ratios
- Must be able to define problems, collect data, establish facts, analyze and interpret information
- Must posess excellent written and verbal communication skills
- Must be able to lift and/or move up to 70 lbs.