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  • Posted: Nov 25, 2021
    Deadline: Not specified
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    54gene was founded in 2019 by Dr. Abasi Ene-Obong to address the significant gap in the global genomics market: Nearly 90% of genetic material used in pharmaceutical research is caucasian. Only 2% is African, despite the fact that Africans and people of African ancestry are more genetically diverse than all other world populations combined.
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    Quality Control Specialist

    Department: Research Operations
    Status: Full-Time, Exempt
    Reports to: Research Data Insights Lead
    Industry: Biotechnology

    Job Summary

    • We are seeking highly motivated and enthusiastic individuals with an eye for detail to join our team at 54gene.
    • The role will be responsible for performing analytical, data review, and/or related activities that support the data insight team in producing clean and quality data.
    • He / She will support in conducting and monitoring the inspection of research studies to ensure compliance with set specifications and troubleshooting data quality issues.

    Essential Functions

    • Review data and assess against established acceptance criteria
    • Perform technical review of peer-generated data for basic methods
    • Prepare data tables and graphs
    • Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
    • Receive and provide training
    • Coordinate with customers to support operational activities.
    • Support internal and external audits.
    • Work to meet schedules.
    • Identify and support resolution of technical problems.
    • Actively participate in group and project teamwork, project, and process improvements.
    • Drafts protocols and reports under supervision.
    • Meets scheduled performance of 95% on time.
    • Perform other duties as requested by managers to support Quality activities.

    Qualifications
    The successful candidate will possess the following skills and experience:

    • Bachelor's Degree, preferably in a Scientific discipline
    • Ability to write clearly and effectively and have good verbal communication skills
    • Ability to exercise sound judgment, reasoning and problem solving.
    • Capable of completing assigned responsibilities and keeping manager informed of status.

    Knowledge, Skills & Abilities:

    • Excellent verbal and written communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment, and have attention to detail and follow-through skills.
    • Excellent organizational skills and the ability and initiative to prioritize and handle a variety of tasks and assignments simultaneously.
    • Excellent time management skills with a proven ability to meet deadlines.
    • Strong analytical and problem-solving skills with the ability to collect, organize, analyses, and disseminate significant amounts of information with attention to detail and accuracy.
    • Must have the ability to exercise good judgment in ambiguous situations under pressure and have strong coping skills.
    • Must have the capacity to comprehend complex structures and connections and be willing to adapt within a rapidly changing environment.
    • 1-2 years' supervisory or equivalent experience in Quality Assurance, Regulatory operations, and Project Management
    • Experience in research, medical or complex administrative setting required, with experience in quality management or quality assurance methodologies.
    • Strong supervisory and leadership skills.
    • Proficient with Microsoft Office Suite or related software and adept at queries, report writing and presenting findings.

    go to method of application »

    Quality Assurance Analyst

    Department: Compliance & Data Protection
    Status: Full-time
    Reports to: Director, Quality Assurance & Risk Management
    Industry: Biotechnology

    Position Summary

    • We are looking for a Quality Assurance Analyst to join our team. You will be responsible for tracking and monitoring controls to ensure they are adequate and effective.
    • To be successful in this position, you will be self-motivated, be able to work with minimal supervision with a good control of time management and industry/regulatory standards.

    Duties and Responsibilities

    • Support business units in the development of cross-functional processes and Standard Operating Procedures.
    • Review functional and high-level process and SOP documentation for quality and adherence to defined methodology and standards.
    • Provide input into the preparation of audit work plan and participate in the periodic evaluation/audits of operational processes.
    • Provides insight into quality gaps discovered as part of the quality assurance process and ensures these gaps are communicated to appropriate management and business owners.  
    • Analyses information gathered to develop recommendations for improvement and changes in current policies and procedures for continued compliance with business Policies/SOPs and applicable regulations.
    • Maintain a tracker of all incidents for corrections and corrective actions.

    Qualifications and Requirements

    • Bachelor's Degree in Finance, Business, IT, or related field.
    • 3 - 5 years of experience in as an analyst in a similar company or related fields
    • Basic knowledge of Quality Assurance techniques, tools, and Quality Management Methodology.
    • Solid knowledge of relevant regulatory and industry standards.
    • Strong attention to detail.
    • Proficiency in the use of Microsoft Word, Excel, Visio or other analysis and drawing programs.
    • Effective time management skills and the ability to meet deadlines.
    • Able to give and receive constructive criticism

    Knowledge, Experience and Skills:

    • Knowledge of Quality Assurance System Development and implementation such as ISO 9001:2015 QMS
    • Quantitative and analytical skills with a demonstrated ability to understand new analytical concepts.
    • Critical thinking skills with the ability to independently solve problems with data.
    • Presentation skills, including public speaking and presentation creation using PowerPoint.
    • Strong written and verbal communication skills to inform managers and other stakeholders of results

    go to method of application »

    Risk Analyst

    Department: Compliance & Data Protection
    Status: Full-time
    Reports to: Director, Quality Assurance & Risk Management
    Industry: Biotechnology

    Position Summary

    • We are looking for a Risk Analyst to join our team. You will be responsible for tracking and monitoring controls to ensure they are adequate and effective.
    • To be successful in this position, you will be self-motivated, be able to work with minimal supervision with a good control of time management and industry/regulatory standard.

    Duties and Responsibilities

    • Conduct risk assessments and monitor business systems to identify potential threats.
    • Evaluate risk exposures (opportunity, hazard, uncertainty etc.) that pose an internal or external threat (political, economic, financial, market, international) and make necessary recommendations.
    • Mitigate potential risk and propose appropriate solutions.
    • Review existing risk techniques and business processes to make improvements.
    • Update the risk management system, monitor regulatory developments, and suggest recommendations/modifications to existing practices.
    • Perform and monitor activities related to the selection, management, and oversight of third-party service providers from a risk management perspective.
    • Update third party risk management procedures, policies, and methodology
    • Prepare and compile agreed periodic Risk activity and performance reports for the attention of the Director, Quality Assurance & Risk Management.

    Qualifications and Requirements

    • Bachelor's Degree in Finance, Business, IT, or related field.
    • 3 - 5 years of experience as an analyst in a similar company or related fields
    • Basic knowledge of Risk Management Methodology, tools, and techniques.
    • Solid knowledge of relevant regulatory and industry standards.
    • Strong attention to detail.
    • Proficiency in the use of Microsoft Excel, PowerPoint or other analysis programs.
    • Effective time management skills and the ability to meet deadlines.
    • Able to give and receive constructive criticism.

    Knowledge, Experience and Skills:

    • Strong numerical and statistical skills
    • Analytical and problem-solving skills
    • Presentation skills and presentation creation using PowerPoint.
    • Excellent written and verbal communication skills to inform managers and other stakeholders of results.
    • Experience working in the risk department of an organization certified to ISO 31000 or similar Standard (e.g. ISO 9001, 14001, 27001 etc.)

    Method of Application

    Use the link(s) below to apply on company website.

     

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