Quality Control Specialist II
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Job Summary
Together with its wholly owned subsidiaries OTIprovides its customers with end-to-end solutions.
Overview
Here atOTIour 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
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 guidelinesestablishedby OraSure Technologies and regulatory bodies.
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 productsand stability programs. Performs customer complaint investigations including required testing and reporting.
- Supports and performs failure investigations and reports on findings with guidance.
- Activelyparticipatesinmanufacturing/engineering studies and validation protocols. Completes all paperwork according tocGLPand cGMP guidelines.
- Maintains a clean organized work area and keeps supplies stockedatthe updating work instructions (WIs)and other associated documents.
- Assistsin the training of Quality Control employees in new methods and procedures and ensures continued compliance within the lab.
- Conducts andwritesreports on product stability testing. Maintains systems to track trends in product and material quality.
- Identifiesand reports on positive and negative product quality trends through trend analysis using statistical analysis tool().
- Orders andtracksinventory and supply items as needed.
- Learn new procedures inan appropriate timeframe andmaintaincompetency.
- 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 withinQualityControl department and in conjunction with other departments.
- Displays positive working relationships and cooperates with work assignments in the best interest of the department.
- Suggests constructivechangeswhereneeded usingappropriate meansof problem solving.
- Refer all complaints to the Quality Control Supervisor or designee.
- Consistently follows OraSure Technologies Inc policiesregardingattendance and punctuality. Respects the property of OraSure 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 OraSure Technologies activities.
- Cross functional work with R&D QA Operations
- Supports OraSure Technologies Inc policies and LIVEIT values (Lead with Integrity Inspire Innovation Value our Customers Embrace Teamwork Impact Success Think Quality).
Requirements
- Proficient withMicrosoft Office (Outlook Word Excel PowerPoint). Familiarity with SharePoint OneDrive 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 yearspreviousGMP laboratory experience.
25000 - 45000 a year
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:
- 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.
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 OTI 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 cluband 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 emailprotected. 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 applicants 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.
Required Experience:
IC
Key Skills
- Academics
- Ale
- Asset Management
- Instrument Maintenance
- Database Administration
- Data Analysis
About Company
OraSure Technologies is a global company that empowers the world to improve health and wellness by providing access to accurate, essential information.
