This position is responsible for inspecting all received materials to ensure they adhere to specifications prior to releasing them into inventory. This position is required to perform sampling activities and accurately document defined information.
Essential Duties and Responsibilities:
- Responsible for visual inspection of incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials
- Receives and assures the incoming material is in compliance to all specifications and releases material into company software
- Perform sampling of critical raw materials that support GMP manufacturing and prepare for confirmatory testing
- Responsible for accurately recording inspection results and maintaining good documentation practices
- Quarantining materials that require additional testing and ensuring released material is properly labeled with accurate information
- Verify all documentation is received, completed and filed accordingly
- Assist in the development of inspection procedures
- Must be able to distinguish between certain colors and pass an annual eye examination
- Accurately document and compare results against certificates/specifications
- Initiate nonconformance reports for failing materials and CAPA related activities
- Create, revise and update standard operating procedures (SOP) as requested
- Mentor and train other QC inspector personnel
- Ensure non-conforming product is properly segregated and quarantined
- Receipt and assures the incoming material is in compliance to all specifications and releases material into company software
- Rejects defective parts, generate non-conformance reports, identify, segregate and follow up on disposition status
- Performs receiving inspection of invoice/ certificate of conformance for compliance
- Issues lot numbers to materials released for use
- All employees are responsible for the general upkeep of work and shared spaces
- Other duties as assigned
- Six months' work experience in related field
- Experience working in a quality environment preferred
- High school diploma
Skills and Knowledge:
- Strong verbal and written communication skills
- Knowledge of materials used in quality control and production processes for maximizing effective inspection and release of products
- Knowledgeable of inspection techniques. Must be able to evaluate ability of procedures, techniques, tools, materials and/or equipment to meet department needs
- Strong attention to detail and accurate record keeping
- Basic computer skills including a word processing, and spreadsheet / data tracking analysis
- Ability to work effectively as part of a cross-functional team
- Ability to read and interpret documents such as safety warnings and various certificates
- Ability to quickly and accurately compare similarities and differences among sets of letters, numbers, pictures or patterns
- Ability to follow written procedures and written or verbal directions
- Ability to manage time performing several different tasks throughout the day
- Ability to work with little supervision
- Ability to adapt to changes in priorities and demonstrate flexibility
- Excellent decision and problem-solving skills
- Good dexterity for hand-to-eye coordination
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.
This position may come in contact with various solutions and chemicals that are typically found in a biological lab.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time. This position routinely works with large pieces of equipment.
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.