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Sample Management Supervisor

Inotiv
Rockville, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Position Requirements

Education and experience

  • B.A. or M.S. in Biology, Biochemistry, Immunology or pharmaceutical sciences.
  • Minimum 5 years (BA) or 2 years (MS) of relevant experience preferred in CRO, biotech or pharmaceutical industry and/or highly regulated environment.
  • Experienced in working with specialized lab software such as Watson LIMS.
  • Capable of multitasking and working under pressure with tight timelines in a dynamic environment.
  • Basic understanding of GLP/GCP management skills.

Skills and abilities

  • Good communication, writing and organizational skills.
  • Responsible for the management and tracking of bioanalytical samples.
  • Ability to oversee the laboratory work, conduct and schedule sample activities in multiple projects.
  • Train and manage sample management team and supervise their tasks by creating work schedules and assignments.
  • Ability to communicate and collaborate with various departments, scientific groups, QC and QA teams, and site management to track the samples.
  • Plan and coordinate sample delivery and operations which includes collection, processing and disposition.
  • Ensure the samples are used and stored appropriately according to the sponsor/client requirements and check on daily basis sample inventory and storage facilities.
  • Support, document and troubleshoot sample quality and access issues on-site.
  • Participate in client, QA and QC meetings and audits, and document any deviation.
  • Working knowledge of Microsoft Access, Word, and Excel.
  • Knowledge in reading, editing and reviewing SOPs, working in compliance to federal regulations (GLP/GCP).
  • Know and understand applicable national and state regulations, with the ability to apply these practices daily.
  • Implement and design sample tracking databases for new studies and develop sample management plans.
  • Working knowledge of and ability to adhere HIPAA regulations

Performance requirements

General

  • Ability to read, write, speak and understand English.

Physical Activity

  • Moderate physical activity.
  • This position will require frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day).
  • Able to wear latex or nitrile gloves, dust mask or respirator, and safety glasses as required.
  • Ability to read and understand applicable materials.
  • Manual dexterity to operate laboratory equipment and calculator/computer.
  • Able to read and interpret test results and instrument specifications.

Working Conditions

  • Work is normally performed in a typical interior office work or laboratory environment.
  • Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include use of protective equipment.
  • The noise level is usually moderate.
  • This position will frequently be involved with radiant/electrical energy, solvents, grease, oil, irritants, acids, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials and biohazards. Due to exposure to hazardous biological material (which may include HIV positive specimens), immunization to Hepatitis B and/or other diseases may be a requirement.

Responsibilities and Duties

Corporate

  • Enter data into databases.
  • Follow SOPs and other applicable laboratory or company procedures.
  • Maintain confidential information.

General

  • Interact with the community and employees.
  • Support and participate in other company initiatives as directed by senior management.
  • Perform other duties as assigned.

Specific

General Sample Group Responsibilities/Duties

  • Oversight for receiving, processing, maintaining, and return/disposal of samples and reference standards for Inotiv.
  • Responsible for management of sample archives including disposing, returning, and billing for the storage of sample archives.
  • Responsible for clinical kit offerings including client interaction, designing, managing inventory supplies and building kits as needed.
  • Responsibility for service and maintenance of stability room equipment.

Managerial Responsibilities/Duties

  • Effective communication with the business development department, principal investigators, clients and client services department.
  • Ensure sample department is providing Inotiv staff guidance on SOP and documentation requirements.
  • Regulatory Responsibilities/Duties.
  • Knowledge or willingness to learn the DOT (and international) Hazmat regulations and maintaining certification for you and your team. (Outside training provided).
  • Responsible for the proper management of scheduled drugs and DEA licensing.

Process Improvement Responsibilities/Duties

  • Evaluation of the current sample storage and receipt department with goal to continuously improve the team cross training and interaction as well as internal and external customer service through building and maintaining processes that support these goals.
  • Document current workflows with a future goal of updating and streamlining processes.
  • Database management.
  • After hours and weekend responsibilities to protect samples in case of freezer failures.

Inotiv

Address

Rockville, MD
20850 USA

Industry

Technology

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