Quality Control Specialist

Jobtailor; Bethlehem (Northampton County); On-site; USD 42,000 - 62,000; Full time

Job summary

OraSure Technologies, Inc. in Bethlehem, PA is seeking a Quality Control professional to perform testing on materials, in-process samples, and finished products, while documenting results in accordance with cGLP and GMP guidelines.

The role includes investigating customer complaints, supporting failure investigations, and contributing to validation studies. Strong attention to detail, teamwork, and effective communication are essential assets for success.

Qualifications

• Experience following SOPs and cGLP/GMP guidelines.
• Ability to perform testing on raw materials, in-process samples, and finished products.
• Strong attention to detail and documentation skills.
• Excellent written and verbal communication.
• Ability to plan, organize, and manage time effectively.
• Willingness to work overtime as needed.
• Bachelor's degree in quality or science discipline preferred.

Responsibilities

• Performs procedures accurately according to WIs and SOPs in Quality Control.
• Performs testing of raw materials, in-process samples, finished products, and stability programs.
• Investigates customer complaints and reports findings.
• Supports failure investigations and validation studies.
• Maintains clean, organized work area and proper paperwork per cGLP/GMP.
• Trains QC lab employees on new methods and procedures.
• Maintains quality systems and tracks trends.
• Orders and tracks inventory and supplies as needed.
• Communicates with supervisors and other departments regarding issues.
• Maintains confidentiality and upholds company policies.

Skills

Quality control

Documentation

Teamwork

Attention to detail

Problem solving

Communication

Education

Bachelor's degree in quality or science discipline

Tools

Microsoft Office

SharePoint

OneDrive

Teams

Job description

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.
• Performs customer complaint investigations including required testing and reporting.
• Supports failure investigations.
• Actively 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.
• Supports in the training of 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.
• Displays positive working relationships and cooperates with work assignments in the best interest of the department.
• Notifies Quality Control Supervisor or designee of equipment and/or procedural problems.
• Recognizes problems and notifies the Quality Control Supervisor or designee.
• Notifies the 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.
• Bachelor's/Undergraduate degree (quality or science discipline preferred).

Core Competencies

Demonstrates expertise in Quality Control procedures, including testing, investigations, and compliance with cGLP and GMP guidelines. Proficient in maintaining quality systems and training laboratory employees while fostering a collaborative work environment.