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.

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.

EDUCATION / EXPERIENCE

Bachelors/Undergraduate degree (quality or science discipline preferred).

PHYSICAL REQUIREMENTS

Work at least a 40-hour schedule weekly.

Ability to work in an office / lab environment and to use appropriate equipment.

Occupational exposure to bloodborne pathogens.

Ability to perform general mobility functions (e.g., sitting, standing, lifting, carrying, reaching, bending, stretching, twisting, turning) with the 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

Travel may be required 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.

COMPETENCIES

Quality Control Procedures: Proficiency in executing established quality control procedures, including sample testing, inspections, and data collection, to assess and ensure product or process quality.

Attention to Detail: Strong attention to detail to accurately identify and document product defects, discrepancies, or deviations from quality standards.

Document Review and Compliance: The ability to review and verify quality control documents, records, and reports for accuracy, completeness, and adherence to quality control protocols and regulatory requirements.

Data Collection and Analysis: Competency in collecting and recording quality data, as well as basic data analysis to assess product quality and identify potential issues.

Problem Identification: The capability to recognize quality issues and deviations from standards and report them for further investigation and resolution.