Essential Duties and Responsibilities:
- Responsible for meeting operational fiscal requirements for current and new business activities.
- Oversee operations with a focus on Quality, Validation, and Facilities compliance using our Standard Operating Procedures (SOPs) and input from our FBS QA and Facilities departments as a guide.
- Develop CAPEX (capital expense) requirements and annual operating budget (AOP) for areas of focus. Review all purchases and invoices generated from your team.
- Interact with clients as necessary to assist in sales and customer service requirements. This includes tours of the facilities and participation in site audits.
- Responsible for data retention and archives, data entry, inventory, shipments, and associated with distribution function of biologicals and associated drug substance.
- Assures client/sponsor documentation is complete, accurate and issued in a timely fashion.
- Responsible for packaging and shipping and all aspects of the logistics function domestic and global to support these operations.
- Responsible for government and regulatory compliance including OSHA, accident reporting, and ensuring compliance to cGMP standards.
- Ensures all employees follow safety guidelines and are properly trained.
- Works closely with the QA Manager to develop and implement training programs for Operations.
- Conducts fair and accurate performance reviews on time, orientation training, and provides periodic feedback and coaching on performance.
- Follow‐up to direct client contact via email or face‐to‐face.
- Day‐to‐day coordination of multiple repository projects in process.
- Other duties may be assigned to meet business needs.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
- Requires ability to communicate effectively verbally and in written form.
- Requires ability to prepare reports using Excel; knowledge of Windows, Word and Access.
- Requires expert ability to work with methods to handle, process, and store specimens using a computerized storage and retrieval system.
- Requires knowledge of Universal Precautions, general laboratory and quality assurance/control.
- Valid driver’s license and good driving record if required to transport material.
- Requires demonstration of good professional judgment when working with clients.
- Requires ability to role model behavior consistent with company values.
- Requires demonstration of strong logic and problem-solving skills.
- Must have high level of integrity and reliability, as database and inventory management are key aspects of the position
- Requires a High School Diploma or equivalent; Degree in a science field preferred.
- Requires 4+ years of progressive experience in a repository/distribution environment.
- Prefer previous supervisory experience.
Certificates and/ or Licenses:
- IATA Dangerous Goods Training for Class 6.2 Shipping.
- Blood Borne Pathogens Training.
Direct supervisor for operations technicians in the commercial repository.
8AM to 5PM core hours, additional hours as required.
Work Conditions/Physical Requirements:
- Must be able to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, and marked changes in temperature.
- May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
- Must use personal protective equipment and adhere to safety protocols.
- Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C).
- Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day.
- Must be able to use a computer up to 6 hours per day.
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