Formulations Specialist
About The Position
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. 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.
Requirements
- 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.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
