Logistics Specialist I
500 Forbes Blvd., SSF56 South San Francisco, CA 94080
Bayside Solutions is seeking a Logistics Specialist I to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Logistics Specialist I
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Execute GMP Environmental Monitoring activities including, but not limited to: alarm checks, equipment inspections, supplemental temperature monitoring, and associated documentation for all sample storage/conditioning CTEs and Cold/Warm Rooms under Device Development Management.
- Manage and maintain GMP Test Sample Inventory documentation and chain-of-custody audit trail per appropriate cGDP standards and requirements.
- Manage all material intake, transfer, and shipment processes for both internal and external materials.
- Record, coordinate, and oversee sample transfers between storage facilities to maintain accurate chain-of-custody audit trails.
- Perform physical counts of material.
- Document and maintain inventory, labeling and organization of all applicable materials including but not limited to devices, products, components, consumables, lab supplies, chemicals, reagents, etc.
- Accurately pull and issue material in support of Manufacturing, Quality, and R&D needs.
- Communicate to lab users and internal stakeholders regarding new procedures, requirements, and potential noncompliance as it relates to laboratory usage, material handling, and waste management.
- Support Technical/Impact assessments for equipment failures, OOS temperature/humidity conditions or adverse and atypical events that occur during the material management sample lifecycle.
- Assist Lab Manager and Lab supervisor in all aspects of the maintenance and operation of the Device and Packaging Development laboratory.
- Maintain lab infrastructure of storage areas, environmental chambers/rooms, temperature mapping/monitoring, and the preventative and calibration of these storage chambers.
- Maintain cleanliness, safety, and usability of laboratories and storage spaces via periodic inspections.
- Collaboration with the Laboratory Supervisor/Manager, Laboratory Engineers, Device Engineers, and Process
- Engineers to identify, develop, and implement new processes to enable safe and efficient operations and material management.
- Support all lab space, storage and inventory goals/initiatives and represent PTDU-D on cross functional projects (e.g. forecasting, procurement, construction, installations, etc.)
- Adhere to all written and electronic procedures, including cGMPs and exercise good documentation practices at all times
- Recognize operational deviations and/or unplanned/atypical events and notify manager/supervisor
- Familiar with compliance and regulatory requirements to be able to support area audit tours.
- Conduct ongoing compliance and safety assurance activities as assigned by the Lab Supervisor/Manager
- Ensure cGDP and cGLP compliance for test samples, chemicals, materials, waste, etc.
- Maintain up-to-date training status on appropriate standards and procedures.
- Report all atypical or unexpected events that occur during GMP activities to Lab Supervisor and/or Lab Manager as needed.
Summary of Qualifications:
- BS/BA in a technical or life sciences field (mechanical, biological, biomedical, chemical engineering/technology) or equivalent
- Experience in GMP environments, and an understanding of the differences between R&D and GMP environments
- 3+ years of direct experience following and maintaining current Good Documentation Practices (e.g. using inventory records, forms, logbooks, document control systems)
- Direct experience in regulated environments following procedures under quality oversight
- Direct experience in chemical handling, waste management and good laboratory practices
- Proficiency with PC desktop applications and business operations software system
- Must be highly organized, analytical, detail oriented and able to conduct work independently
- Team oriented, creative, eager to take on responsibility
- Excellent written and verbal communication skills
- Demonstrated ability to communicate with internal stakeholders and external collaborators.
- Must be able to lift > 50 lbs, push/pull > 100 pounds of force
- Must be suitable for TSA security clearance
- Previous experience with warehouse equipment (e.g. pallet jacks, fork lifts, wrappers, etc.) a plus
- Previous or current Class B License a plus