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Supervisor, Clinical Kit

Company: BioAgilytix
Location: San Diego
Posted on: January 15, 2022

Job Description:

BioAgilytix is a leading contract research organization (CRO) that specializes in large molecule bioanalysis. Our fully integrated laboratory services support every stage of biologics development, from early discovery through pre-clinical studies and clinical phases, in a fully regulated environment. The best science demands the best people, and our global team of professionals in Durham, North Carolina; Boston, Massachusetts; and Hamburg, Germany bring a passion for helping pharma and biotech companies achieve more for the patients they serve.

The Supervisor, Clinical Kit is responsible for supervising the Clinical Kit department. He or she assists the technical team members with assembly and release of clinical kits to meet client expectations and maintain a high level of quality through communication, customer service, and organizational practices.
Essential Responsibilities

  • Supervises the organization and day-to-day operations of the Clinical Kit department
  • Act as liaison to clients
  • Manages and coordinates the assembly and release of clinical kits
  • Performs and maintains documentation and compliance standards with adherence to USFDA, OECD, and MHLW Good Laboratory Practices regulations as required
  • Reviews protocols to determine type of kit needed (i.e., timepoints, anticoagulant, vacutainers)
  • Creates clinical kits including but not limited to verifying supplies needed, designing/formatting labels, labeling/handling instructions, and creating kit binders
  • Coordinates with sites to obtain contact information, receive kit requests, and follows through with site to ensure correct kit usage
  • Completes kit work orders, assembly, and shipping; coordinating with couriers to ensuring kits arrive at destination, resolving customs/invoicing issues, and ordering courier supplies as needed
  • Maintains supplies
  • Maintains a professional image particularly when dealing with sites
  • Assists in special projects as assigned by the Senior Manager of Project Operations
  • Follow BioAgilytix standard operating procedures (SOPs)
  • Other duties as assignedMinimum Acceptable Qualifications

    Education/Experience:
    • High School diploma
    • Not less than three (3) years' experience in a GxP-regulated laboratory or clinical environment; clinical kit experience preferredSkills:
      • Working knowledge of GxP regulations
      • Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
      • Ability to take direction well and multi-task
      • Acute attention to detail and excellent organizational skills
      • Excellent oral and written communication skills
      • Proficiency in MS Excel and Word
      • Proficiency in LIMS and Quality Management software packages
      • Excellent written and verbal communication skills; ability to communicate to multiple audiences
      • Strong interpersonal skills with the ability to work with all levels of management and employees; ability to gain credibility, provide excellent customer service, and foster positive working relationships with internal and external stakeholdersPreferred Credentials
        • Associate degree in molecular biology, chemistry, biochemistry, immunology, biotechnology, or related field with not less than one (1) year of experience in a GxP-regulated laboratory or clinical environment
        • Bachelor's degree in molecular biology, chemistry, biochemistry, immunology, biotechnology, or related fieldBenefits and Other Perks
          • Medical Insurance (HDHP with HSA; PPO)
          • Dental Insurance
          • Vision Insurance
          • Flexible Spending Account (medical; dependent care)
          • Short Term Disability - Long Term Disability
          • Life Insurance
          • Paid Time Off (4 weeks per year)
          • Paid Holidays (9 scheduled; 3 floating)
          • 401k with Employer Match
          • Employee Referral Program (up to $10k)
          • Free Coffee, Tea, Fruit, and Snacks
          • Discounted Vending Machines (25 cents for everything!)
          • Team Wellness Challenges/EventsDisclaimer
            The tasks, duties, and responsibilities listed in this job description are not exhaustive. BioAgilytix, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities to employees. Equivalent experience, skills, and/or education may be substituted for certain requirements, so qualifications of incumbents may differ from those listed in the job description. The Company, at its sole discretion, will determine what is considered equivalent to the qualifications described above. Further, this job description does not constitute a contract of employment, either expressly, or by implication. Comments BioAgilytix requires that all employees be legally authorized to work in the United States. In the event an applicant does not have current work authorization, BioAgilytix will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on USCIS requirements, not all roles are suitable for sponsorship. Equal Opportunity Employer BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

Keywords: BioAgilytix, San Diego , Supervisor, Clinical Kit, Healthcare , San Diego, California

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