OraSure Technologies Inc. (OTI) empowers the global community to improve health and wellness by providing access to accurate, essential information. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market.
Together with its wholly owned subsidiaries, OTI provides its customers with end-to-end solutions.
It’s first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and Hepatitis C (HCV) on the OraQuick® platform; sample self-collection and stabilization products for molecular applications; and oral fluid laboratory tests for detecting various drugs of abuse.
Overview
Here at the OTI our innovative sampling tools and diagnostics unlock access to accurate, essential information that advances global health and well-being. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.
SUMMARY / OBJECTIVE
Quality Control Specialist I personnel perform procedures that include evaluation of raw materials, in-process samples, finished products, stability testing, and lab equipment maintenance and troubleshooting in compliance with guidelines established by OraSure Technologies and regulatory bodies.
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.
