Senior Operations Technician

Actalent · Frederick, MD · 2 mo ago

On-siteManagement$25–$29/hrContract

Actalent is seeking an Operations Technician III to manage the receipt, inventory, storage, withdrawal, and shipment of biological specimens, clinical agents, and materials for commercial and government clients. This role involves handling materials stored at temperatures from ambient to -196°C, including potentially hazardous substances, while adhering to strict safety and regulatory guidelines.

Responsibilities

Prepare samples and clinical agents for pickups, courier deliveries, and outbound shipments in accordance with established procedures and client specifications.
Use inventory management systems for accurate data entry, sample tracking, and overall management of biological specimens and materials.
Maintain files and documentation to validate data, prepare queries, review accumulated data for accuracy, and generate reports related to information and sample data.
Receive, handle, and inventory specimens of human, animal, and plant origin at temperatures ranging from ambient to -196°C, including materials with potentially hazardous properties.
Perform internal specimen consolidation and reorganization projects under the guidance of lead staff and independently as experience increases.
Work closely with leadership to support customer inquiries, resolve discrepancies, maintain inventory accuracy, and complete database updates.
Participate in process improvement activities to enhance repository workflows, data integrity, and operational efficiency.
Ensure compliance with current Good Manufacturing Practices (cGMP) CFR parts 210 and 211 and internal quality systems where applicable.
Follow standard operating procedures (SOPs), facility safety guidelines, universal precautions, and applicable Food & Drug Administration (FDA) requirements.
Prepare sample collection kits in accordance with Standard Work Instructions and established quality standards.
Perform commercial packaging and labeling activities, including batch record documentation, to meet client and regulatory requirements.
Travel to other facilities as needed to support business requirements and cross-site operations.
Compile data for the storage and retrieval of specimens and for the preparation of operational and client reports.
Assist in training peers according to SOPs in equipment use, storage and retrieval methods, serum separation, aliquoting, general laboratory procedures, and systematic data entry.
Contribute to the development and refinement of standard operating procedures for repository and laboratory processes.
Conduct investigations to determine specimen movement history and recommend resolutions for inventory inaccuracies and discrepancies.
Resolve complex discrepancies involving identification modifications, duplicate or redundant entries, and database corrections as directed by client instructions or supervisory guidance.
Verify materials prior to shipment and confirm the accuracy of data entry records for incoming and outgoing materials.
Process biological samples according to client specifications, including blood-component separation and aliquoting.
Support printing services by printing labels and materials, compiling job packets, maintaining supply inventories, and performing minor preventive maintenance on thermal transfer label printers.
Mentor and participate in the training of peers, serving as a resource for technical questions and best practices.
Maintain repository files for validation of data, review accumulated data for accuracy, and prepare detailed reports of information and sample data.
Troubleshoot facility equipment issues, identify root causes, and provide suggestions or solutions for implementation.
Take over mid-process projects initiated by others, determine the appropriate path forward, and ensure projects are completed accurately and on time.
Lead printing proof implementation and maintenance processes, collaborating with Quality Assurance, Client Services, and Technical Services to ensure label accuracy and compliance.
Lead printing services processes to ensure all requests are completed on schedule and that supplies are properly maintained and available.
Lead and complete labeling services and associated batch records, ensuring documentation is accurate and compliant.
Provide follow-up to direct client contact via email or in person, offering customer service solutions of moderate impact.
Coordinate day-to-day activities across multiple repository projects in process, managing priorities and timelines.
Perform other related duties as assigned to support evolving business and operational needs.

Requirements

Minimum of 2+ years of repository work experience involving data entry, shipping and receiving, and sample management.
Minimum of 2+ years of experience in packaging, labeling, and batch record documentation in a regulated or controlled environment.
Ability to safely work with cold chain materials including Dry Ice, Liquid Nitrogen (LN2), and -80°C freezers.
High School Diploma is required; a Bachelor’s degree in a science-related field is preferred.
IATA Dangerous Goods Training for Class 6.2 shipping is required or the ability to obtain it within a designated timeframe.
Bloodborne pathogens training or equivalent safety training related to handling biological materials is required or the ability to obtain it.
Valid driver’s license and good driving record when required to transport materials between facilities.

Skills

Proven ability to communicate effectively both verbally and in written form with internal teams and external clients.
Expert ability to prepare reports using Microsoft Excel, including data organization, analysis, and presentation.
Working knowledge of Windows operating systems and proficiency with Microsoft Word; familiarity with Microsoft Access is advantageous.
Expert ability to handle, process, and store specimens using computerized storage and retrieval systems in a repository environment.
Knowledge of universal precautions, general laboratory practices, and quality assurance and quality control principles.
Strong understanding of cGMP CFR parts 210 and 211 and the ability to follow FDA-related requirements and company quality systems.
Ability to use inventory management systems for data entry, sample tracking, and inventory control.
Demonstrated good professional judgment when interacting with clients and making operational decisions.
Ability to role model behavior consistent with organizational values such as integrity, intensity, innovation, and involvement.
Strong logical reasoning and problem-solving skills to resolve discrepancies and troubleshoot equipment and database issues.
Self-driven work style with the ability to function independently and complete tasks without continual oversight.
High level of integrity and reliability, especially in managing databases, inventory records, and sample documentation.
Preferred experience working in cold chain environments, including handling Dry Ice, Liquid Nitrogen (LN2), and ultra-low temperature freezers.
Preferred work experience with data entry, shipping and receiving, batch record management, labeling, and sample management in a laboratory or repository setting.
Experience with Optel, Codesoft, label printing, and barcode grading is preferred.
Familiarity with serum separation and aliquoting techniques and general laboratory procedures.
Experience supporting printing services, including operation and minor preventive maintenance of thermal transfer label printers.
Comfort working with computerized inventory systems and repositories that manage biological specimens at a range of temperatures.
Ability to travel to other facilities as needed to support business operations.

Work Environment

This role operates in a sterile, warehouse-style repository environment that houses freezers and Liquid Nitrogen tanks. The work involves frequent exposure to cold chain conditions, including Dry Ice, Liquid Nitrogen (LN2), and -80°C freezers, as well as ambient temperature storage areas. The position follows a Monday through Friday schedule, approximately 8:00 a.m. to 5:00 p.m., with the potential for occasional travel to other facilities based on business needs. Work is performed around specialized equipment for sample storage, retrieval, and printing, and requires adherence to strict safety protocols, universal precautions, and standard operating procedures. Team members typically wear appropriate laboratory or warehouse attire and personal protective equipment suitable for working with biological specimens, cold environments, and hazardous materials.

Pay

The pay range for this position is $25.00 - $29.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital insurance
401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

Monday through Friday, approximately 8:00 a.m. to 5:00 p.m., with the potential for occasional travel to other facilities based on business needs.