Formulations Specialist

Job Description

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

Manufacture chemical formulations necessary for production of finished goods, document production information, and perform routine maintenance on equipment/machinery.

• Coordinate and prepare all chemical formulations 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).
• Evaluate reagents, raw materials, and in-process components through visual and performance testing according to specifications.
• Recommend acceptance or rejection of raw materials and in-process components based upon established specification and procedures.
• Assist in training new Formulation personnel 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 or process discrepancy in accordance with established escalation policy.
• 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.
• Assist in writing and performing validation protocols, nonconformance investigations, and planned deviation investigations.
• Be responsible for the accuracy and completeness of material inventory records. Notify appropriate area supervision to order inventory and supply items as needed.
• 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. .

• 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

BS in chemistry, biochemistry, or equivalent with one (1) to three (3) years of applicable working experience.

PHYSICAL REQUIREMENTS

Ability to work in a laboratory and manufacturing environment.

Physical demands for this role may include the ability to stand or sit for extended periods, operate specialized manufacturing and/or lab equipment, lift and move moderate to heavy loads up to 25 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 meetings, training, audits, or collaboration with other company locations or external partners.

ORGANIZATIONAL RELATIONSHIPS / RESPONSIBILITIES
This individual contributor reports to Formulations 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  

OTI recognizes that the long-term health of our business is directly connected to the health of the planet, local communities and the OTI family of companies employees.  

- 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 View email address on ziprecruiter.com. 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. 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.