Job Description

The purpose of Sample Management is the responsibility of managing samples on behalf of the sponsor. Sample Management Supervisor is accountable for tracking, storing, shipping, receiving, and entering critical data via Watson LIMS.

Key Accountabilities

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 Other duties as assigned.

Minimum

Requirements

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.

Skill & Competencies

Enter data into databases. Follow SOPs and other applicable laboratory or company procedures. Maintain confidential information. Interact with the community and employees. Support and participate in other company initiatives as directed by senior management. 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.

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.

Working Conditions & Physical Requirements

Extended computer and display screen equipment usage 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. Ability to push, pull, lift 5 0 pounds unassisted. Stand / walk for extended period of time. Fine manipulation including handle touch object or tools and ability to handled controls to perform work. Ability to read and interpret materials, verbally communicate, and hear required. The anticipated starting salary for this position is $62,00.00 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience.

This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.*

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.