Under limited supervision, serves as technical expert to cGMP operations in one or more core distribution functions(s): receiving, storing, dispensing, transferring or shipping materials per standard operating procedures or guidelines.
Functions
Receive, store, dispense, deliver, transfer, reconcile, cycle count, or ship materials per cGMP procedures and regulations, within multiple systems and/or between multiple sites.
Proficient use of inventory system(s) allowing staff member to resolve basic system issues within Company's ERP system.
Proficient use of multiple quality, operations and logistical software applications including: read, write access Review and verify cGMP transactions
Use of Power Industrial Vehicles (PIV) to move warehouse materials.
May operate trucks (flat bed or panel) to move warehouse materials, hazardous materials or general receiving goods following Department of Transportation regulations.
Receive, deliver, store, transfer, or ship hazardous materials per Federal guidelines.
Adhere to OSHA, DOT and company policies and regulations, and others as required.
Identify and report operational issues and process improvement opportunities to leadership.
Participate in group/dept specific projects.
Maintain compliant training records.
Maintain clean and safe work environment.
Prepare for regulatory inspections and audits.
Power user of inventory system(s) allowing staff member to effectively troubleshoot and resolve system issues within Company's ERP.
Power user of multiple quality, operations and logistical software applications including read, write and owner access.
Identify and report operational issues and process improvement opportunities to leadership, and propose solutions and assist in addressing.
Participate in or lead group/dept specific projects.
May monitor required training of others
May train staff in basic cGMP functions, and other functions (i.e. CFR, DOT, OSHA).
May monitor work processes to ensure compliance and successful completion of metric targets.
May review department's standard operation procedures, training materials, validation documents to ensure completeness and accuracy.
May serve as a point of contact to internal and some external customers for daily operational matters.
May consolidate and report department performance metrics.
Technical expert in the receipt, storage, dispensing, delivery, transfer, reconciliation, cycle counting, or shipment of materials per procedures and regulations.
Area expert in the transfer or shipment hazardous materials per Federal and approved shipment guidelines.
Power user able to effectively troubleshoot and resolve system issues within Company's ERP, suggest soft and hard code changes for identified efficiencies.
Identify and report operational issues and process improvement opportunities to leadership, propose solutions, lead efforts to address.
Participate in or lead group/dept specific, or multi-departmental projects.
Ensure others receive and maintain required training.
Able to train staff in range of cGMP and operational functions.
Regularly review department's standard operation procedures, training materials, validation documents to ensure completeness and accuracy, update as required.
May serve as group's primary point of contact to internal and external customers for non-routine operational issues, includes investigating and resolving issues.
Consolidate and report department performance metrics.
Adhere to and enforce cGMP, OSHA, DOT, and Company policies and regulations, and others as required.
Ensure clean and safe work environment - this may include serving as an RSO for the functional area.
Prepare for and participate in regulatory inspections and audits.
May provide direction to and/or mentor other staff.
Qualifications
High school/GED + 2 years of directly related work experience and/or military experience OR Associate’s + 6 months of directly related work experience and/or military experience.
Preferably experience in SAP, EBR, Forklift for components and product movement.
Availability to work non-standard shifts, overtime, and weekends.
Competencies/Skills
Demonstrates Company values.
Ability to safely operate trucks or vans.
Ability to safely handle, transport and manage hazardous materials.
Ability to operate warehouse equipment, e.g. forklift, pallet jack, special purpose cryogenic equipment, potent compound equipment, etc.
Keen attention to details.
Ability to carefully and accurately follow complex written procedures.
Ability to assemble, disassemble, operate and understand complex equipment or processes per procedures.
Strong computer skills.
Ability to operate efficiently and effectively within multiple software applications.
Intermediate mathematical skills.
Good written and verbal communication skills.
Ability to prioritize work to meet deadlines.
Ability to understand and adhere to cGMP.
Good problem solving skills.
Ability to interact constructively with peers and clients.
Ability perform effectively in a fast paced, team environment.
Ability to work as a team and/or independently.
Basic customer service skills.
Comprehensive understanding of processes, systems, and responsibilities in primary area of responsibility.
Good understanding of departmental, cross-functional and major customers processes, systems and responsibilities.
Power user level computer skills.
Ability to work with various software applications and perform minor troubleshooting.
Good organization skills.
Ability to draft/revise controlled documents or business processes.
Basic presentation skills.
Strong customer service skills.
Ability to prioritize, schedule and coordinate work to meet deadlines
Ability to effectively communicate and resolve issues.
Strong multi-tasking skills.
Understand and administer DOT regulations.
Ability to train others.
Ability to effectively interact with regulators.
Has in-depth understanding of material movement flow, touch points and interdependence of various processes and systems.
Comprehensive understanding of departmental, cross-functional and major customers processes, systems and responsibilities.
Strong power use level computer skills.
Ability to work with various software applications and perform troubleshooting.
Basic technical writing skills.
Solid presentation and facilitation skills.
Complex problem solving skills.
Ability to prioritize, schedule and coordinate own work and work of others to meet deadlines.
Ability to effectively present or explain a process or system to regulators.
Basic project management skills.
Ability to lead others without direct authority.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers health benefits that include vision, dental, and pharmacy. Additional benefits offered to eligible employees include a 401K retirement plan with employer matching, a referral bonus program, and an EAP (Employee Assistance Program). SPECTRAFORCE provides unpaid leave as well as paid sick leave and vacation when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at benefits_pr@spectraforce.com if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $20.43/hr.
