Quality Control Specialist I

Quality Control Specialist I

Here at Ora Sure Technologies Inc. (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 I 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.

Essential Functions & Responsibilities:

• 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 failure investigations.
• Actively participates in performing manufacturing/engineering studies and validation protocols.
• Completes all paperwork according to cGLP and GMP guidelines.
• Maintains a clean, organized work area and keeps supplies stocked at the bench.
• Supports in the training of Quality Control laboratory employees in new methods and procedures.
• Conducts and writes reports on the product stability testing, with assistance.
• Maintains systems to track trends in product and material quality.
• Orders and tracks inventory and supply items as needed.
• Learns new procedures in an appropriate time frame and maintains competency.
• 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.
• Notifies Quality Control Supervisor or designee of equipment and/or procedural problems.
• Recognizes problems 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).
• Suggests constructive change where needed using appropriate means of problem solving.
• Refers 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.
• Maintains confidentiality with regards to Ora Sure Technologies activities.
• Performs other job duties and special assignments and projects as put forth by the Quality Control Supervisor or designee.
• Supports Ora Sure Technologies, Inc policies and LIVEIT values (Lead with Integrity, Inspire Innovation, Value our Customers, Embrace Teamwork, Impact Success, Think Quality).

Requirements:

• Basic knowledge of 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.
• Strong attention to detail and good problem-solving skills
• Well-developed communication skills both written and oral
• Flexible and able to work overtime as needed.

Education / Experience:

• Bachelors/Undergraduate degree (quality or science discipline preferred).

Physical Requirements:

• Work at least a 40-hour schedule weekly. Ability to work in an office / lab environment and to use appropriate equipment.
• Occupational exposure to blood borne pathogens.
• Ability to perform general mobility functions (e.g., sitting, standing, lifting, carrying, reaching, bending, stretching, twisting, turning) with the ability to lift, tug, or pull up to 50lbs.
• Ability to sit or stand for extended periods of time - up to 4 hours at a time.

Travel Requirements:

• Travel may 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.

Competencies:

• Quality Control Procedures:
  Proficiency in executing established quality control procedures, including sample testing, inspections, and data collection, to assess and ensure product or process quality.
• Attention to Detail:
  Strong attention to detail to accurately identify and document product defects, discrepancies, or deviations from quality standards.
• Document Review and Compliance:
  The ability to review and verify quality control documents, records, and reports for accuracy, completeness, and adherence to quality control protocols and regulatory requirements.
• Data Collection and Analysis:
  Competency in collecting and recording quality data, as well as basic data analysis to assess product quality and identify potential issues.
• Problem Identification:
  The…