QA Validation Internship (Science/Engineering)
|Title:||QA Validation Internship (Science/Engineering)|
- Applies existing validation programs for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems.
- Maintains validation programs for existing equipment, utility commissioning and qualification, and computer systems.
- Drafts, reviews, and executes protocols and reports related to equipment, facility, and computer validation. This includes deviation reporting during execution.
- Provides statistical support for Quality Systems monitoring and review.
- Assists in customer / regulatory audits and responding to audit observations and corrective actions.
- Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
- Files and maintains controlled documents.
- Other duties as assigned.
- Current 3rd or 4th year undergraduate student in technical discipline (e.g. biology, biotechnology, engineering) or related life science program
- Ability to use Excel, Word, and other office systems
- Ability to understand and independently apply GMPs to everyday work with regard to documentation and review.
- Ability to apply applicable regulatory authority and guidelines with training.
- Demonstrates theoretical understanding of the work tasks assigned.
- Ability to operate within a clean room environment as needed.
- Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
- Ability to learn and use quality management software (e.g. TrackWise(R), ComplianceWire(R)).
- Ability to learn and retain technical information.
- Executes routine procedures and process with high quality.
- Ability to operate assigned office equipment.
- Ability to complete investigation, deviation, and change control forms with initial consultation from supervisor as needed
- Capable of learning of unfamiliar principles or techniques with training.
- Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.
- Edits Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports independently and accurately.