Quality Control Specialist I

Essential Functions & Responsibilities

• Performs all procedures accurately and according to written work instructions (WIs) and standard operating procedures (SOPs) as applicable to the Quality Control department
• Performs testing including raw materials, in-process samples, finished products and stability programs
• Supports customer complaint investigations including required testing and reporting
• Supports failure investigations
• Participates in performing manufacturing/engineering studies and validation protocols
• Completes all paperwork according to cGLP and GMP guidelines
• Maintains a clean, organized work area and keeps supplies stocked at the bench
• Trains Quality Control laboratory employees in new methods and procedures
• Conducts and writes reports on the product stability testing, with assistance
• Maintains systems to track trends in product and material quality
• Orders and tracks inventory and supply items as needed
• Learns new procedures in an appropriate time frame and maintains competency
• Demonstrates a cooperative attitude when performing duties within Quality Control department and in conjunction with other departments
• Notifies Quality Control Supervisor or designee of equipment and/or procedural problems
• Notifies Quality Control Supervisor or designee of any nonconforming product according to the Corrective and Preventive Action System (CAPA)
• Suggests constructive change where needed using appropriate means of problem solving
• Refers all complaints to the Quality Control Supervisor or designee
• Consistently follows OraSure Technologies, Inc policies regarding attendance and punctuality
• Respects the property of OraSure Technologies, Inc and other employees
• Maintains confidentiality with regards to OraSure Technologies activities
• Performs other job duties and special assignments and projects as put forth by the Quality Control Supervisor or designee
• Supports OraSure Technologies, Inc policies and LIVEIT values (Lead with Integrity, Inspire Innovation, Value our Customers, Embrace Teamwork, Impact Success, Think Quality)

Requirements

• Basic knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint)
• Familiarity with SharePoint, OneDrive, and Teams
• Strong planning, organizational, and time management skills
• Ability to consistently follow quality and safety protocols
• Self-motivated and able to work independently and within a team environment
• Strong attention to detail and good problem-solving skills
• Well-developed communication skills both written and oral
• Flexible and able to work overtime as needed

Education / Experience

• Bachelor's/Undergraduate degree (quality or science discipline preferred)

Physical Requirements

• Work at least a 40-hour schedule weekly
• Office / lab environment
• Occupational exposure to bloodborne pathogens
• General mobility functions (e.g., sitting, standing, lifting, carrying, reaching, bending, stretching, twisting, turning)
• Ability to lift, tug, or pull up to 50lbs
• Ability to sit or stand for extended periods of time - up to 4 hours at a time

Travel Requirements

• May be required to travel to support local Bethlehem, PA sites within a 10 mile radius
• Additional limited travel upon request may be required for meetings, training, audits, or collaboration with other company locations or external partners