Manufacturing Technician

OraSure Technologies, Inc.; Bethlehem (Northampton County); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Healthcare coverage

401K plan

Paid time-off

Maternity leave

Job summary

OraSure Technologies, Inc. is seeking a manufacturing technician to assemble components, document production information, and maintain equipment per SOPs and batch records.

You will operate with a focus on quality, safety, and regulatory compliance, reporting issues to supervision as needed. The role runs 2nd shift (4:00pm-2:30am, Monday-Thursday) at the Bethlehem, PA site, with cross-functional teamwork to drive improvements across QA, engineering, and supply chain.

Qualifications

• Follows SOPs, batch records, and work instructions to meet quality and safety standards.
• Maintains accuracy in production records and uses SAP for data entry.
• Operates and maintains production equipment per procedures and WIs.
• Assists in training new technicians on SOPs and safety protocols.

Responsibilities

• Assemble product components per BPRs and WIs.
• Set up, operate, and maintain production equipment.
• Record labor and material for inventory control (SAP).
• Identify and report quality or safety concerns to supervision.
• Collaborate with QA, engineering, and supply chain to drive improvements.
• Ensure compliance with FDA, GMP, and ISO standards.

Skills

Follow detailed instructions

Attention to detail

Communication & teamwork

Basic computer skills

Mechanical aptitude

Measuring equipment

Education

High school diploma

Technical certification

Tools

SAP

Microsoft Word

Excel

Job description

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. This role is 2nd shift (4:00pm-2:30am, Monday-Thursday).

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, elevate, 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.

OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous, consistent, and equitable standard to the assessment of all candidates, regardless of race, color, national origin, sex (including pregnancy), sexual orientation, gender identity, disability status, age, religion, veteran status or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong.

What we have to offer:

• Tiered Medical PPO, EPO, Vision and Dental coverage
• Disability and Life Insurance Benefits
• Generous 401K plan and company-matching contributions
• Highly competitive paid time-off
• Maternity Leave and Parental Leave Coverage
• Employee Referral Program – you may be eligible for a cash bonus if your referrals are hired
• Employee Assistance Program
• Employee Service Recognition
• Job-related Training Programs
• Ability to participate in Teams, Committees, Events and Clubs
• Depending on the role you may be eligible to work in a hybrid environment or fully remotely
• Free Onsite Parking

Please note, the above applies to full-time permanent positions.

Culture, People & Community

• LIVE IT Committee – committed to creating an environment that embodies our values
• All Means U: Employee Committee on Belonging hosts various events across all company locations such as monthly book club and mentorship program
• Wellness Committee empowers colleagues to make critical decisions to improve and protect health
• Sustainability Committee aims to minimize impact on the environment
• Social Committee who organize and run events for both remote and onsite employees, to create connection and community

At OTI, we have a clear vision; cultivate an environment of equal employment opportunity where we do not tolerate discrimination or allow the harassment of employees or applicants on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by law with regard to any employment practices.

OTI aims to create and foster workplaces that reflects and contributes to the global communities in which we do business and the customers and partners we serve. This includes all communities impacted by our corporate presence. As part of this commitment, OTI and its subsidiaries will ensure employees and applicants are provided reasonable accommodation per request. If you require disability-related accommodation during the recruitment process, please contact Katheryn Viau at [e-mail]. OTI will consult with all applicants who request disability-related accommodation during the recruitment process to ensure that the accommodation provided takes into account the applicant’s individual accessibility needs.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.