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
Assemble product components, document production information, and perform routine maintenance on equipment/machinery.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

Perform manufacturing processes according to batch production records (BPRs), standard operating procedures (SOPs), and work instructions (WIs) to ensure adherence to quality, safety, and regulatory requirements.

Identify, escalate, and report quality and/or safety concerns to appropriate area supervision.

Set up, operate, and maintain production equipment in accordance with batch production records (BPRs), standard operating procedures (SOPs), and work instructions (WIs).

Assist in training new manufacturing technicians on standard operating procedures (SOPs), safety protocols, and manufacturing processes to ensure consistency and adherence to quality, safety, and regulatory standards.

Report any equipment malfunction in accordance with established escalation policy.

Use established tracking system to record and report equipment down time events.

Maintain accurate production records and batch documentation to ensure traceability.

Accurately record all labor and material for entry into inventory control system (SAP).

Collaborate with cross-functional teams, including quality assurance, engineering, and supply chain, to drive process improvements, optimize efficiency, and resolve manufacturing issues.

Comply with all applicable regulatory guidelines, such as FDA regulations, ISO standards, and Good Manufacturing Practices (GMP).

Contribute to continuous improvement initiatives, suggesting ideas to enhance productivity, reduce waste, and improve quality in manufacturing processes.

QUALIFICATIONS

Proficient in following detailed instructions and standard operating procedures.

Strong attention to detail and ability to consistently follow quality and safety protocols.

Effective oral and written communication and teamwork skills, with the ability to collaborate with colleagues across different departments.

Basic computer skills, including proficiency in using manufacturing software and systems for data entry and record-keeping. Familiarity with Microsoft Word and Excel is desirable.

Strong mechanical aptitude for general equipment maintenance is required.

Proficiency in utilizing calculators, balances, and various measuring equipment is essential.

EDUCATION / EXPERIENCE

1-3 years of previous manufacturing/production work is preferred.

High school diploma or equivalent; technical certification or vocational training in manufacturing or a related field is preferred.

PHYSICAL REQUIREMENTS
Physical demands for this role may include the ability to stand or sit for extended periods, operate specialized manufacturing equipment, lift and move moderate to heavy loads up to 50 pounds, and engage in repetitive tasks. Additionally, employees should be prepared for the use of personal protective equipment (PPE) and adherence to stringent safety protocols, ensuring a safe and controlled work environment. The role may also involve occasional bending, reaching, and fine motor skills for tasks related to precision assembly or quality control.

TRAVEL REQUIREMENTS
Travel will be required to support local Bethlehem, PA sites within a 10 mile radius. Additional limited travel upon request may be required for training, audits, or collaboration with other company locations or external partners.

ORGANIZATIONAL RELATIONSHIPS / RESPONSIBILITIES
This Individual Contributor reports to Manufacturing/Operations leadership.

Manufacturing Technician

About this role

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

QUALIFICATIONS

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