Quality Control Specialist II

Overview

Here at 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.

Quality Control Specialist II 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 Ora Sure Technologies and regulatory bodies.

• 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 and performs failure investigations and reports on findings with guidance.
• Actively participates in manufacturing/engineering studies and validation protocols. Completes all paperwork according to cGLP and cGMP guidelines.
• Maintains a clean, organized work area and keeps supplies stocked at the bench. Assists in updating work instructions (WIs) and other associated documents.
• Assists in the training of Quality Control employees in new methods and procedures and ensures continued compliance within the lab.
• Conducts and writes reports on product stability testing. Maintains systems to track trends in product and material quality.
• Identifies and reports on positive and negative product quality trends through trend analysis using statistical analysis tool (e.g. Minitab).
• Orders and tracks inventory and supply items as needed.
• Learn new procedures in an appropriate time frame and maintain competency.
• Effectively prioritizes workload in response to production needs.
• Recognizes and troubleshoots quality or equipment issues 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).
• 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.
• Snergists constructive changes where needed using appropriate means of problem solving.
• Refer all complaints to the Quality Control Supervisor or designee.
• Consistently follows Ora Sure Technologies, Inc policies regarding attendance and punctuality. Respects the property of Ora Sure Technologies, Inc and other employees.
• Notifies Quality Control Supervisor or designee of equipment and/or procedural problems.
• Performs other job duties and special assignments and projects as put forth by the Quality Control Supervisor or designee.
• Maintains confidentiality with regards to Ora Sure Technologies activities.
• Cross functional work with R&D, QA, Operations,
• Supports Ora Sure Technologies, Inc policies and LIVEIT values (Lead with Integrity, Inspire Innovation, Value our Customers, Embrace Teamwork, Impact Success, Think Quality).

• Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint). Familiarity with SharePoint, One Drive, 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.
• Well-developed communication skills both written and oral
• Flexible and able to work overtime as needed.
• Education
• Bachelors/Undergraduate degree (quality or science discipline preferred)
• 3+ years previous GMP laboratory experience

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.

• Private Insurance – which includes supplemental health coverage and dental coverage
• Life Insurance Benefits
• Pension scheme
• 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.