SUMMARY/OBJECTIVE:
Under minimal supervision, the incumbent provides support for assigned projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interpret client project requirements and manage related activities to ensure deliverables are met. This includes, but is not limited to creation of item masters, purchase orders, sales order, work orders, customer shipments (order entry / pick ticket) and Distribution/Logistics activities.
- Provide support to the Project Management team for study start up initiatives.
- Draft study specific Master Batch Records, Distribution Protocols, Returns Protocols and Work Orders. Routing required documents for collaboration and approvals utilizing our internal systems.
- Process distribution shipments for ALL studies.
- Coordinate the receipt/release of incoming material by generating the required PO’s, material specifications and obtaining the necessary release documentation.
- Work with cross-functional team members and external suppliers / vendors to ensure project related tasks are understood and delivered on time.
- Participate in client meetings, including development of agendas and meeting minutes.
- Maintains effective communication and working relationships among project team.
- Identify, monitor, communicate and resolve issues, scope changes, or other project objective hurdles that may arise during project execution.
- Prepare and present project progress reports and presentations as required.
- Exercise independent judgment with respect to matters of importance. This may include but is not limited to decision making that impacts activities associated with clinical trial drug delivery, or other project related commitments that are critical to production startup, maintenance or close out activities.
- Review project related inventory to avoid stock out scenarios.
- Carries out duties in compliance with all federal and state regulations and guidelines.
- Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.
- Remains current in profession and industry trends.
- Makes a positive contribution as demonstrated by:
- making suggestions for improvement
- learning new skills, procedures, and processes.
- Is available for other duties as required.
- Is available for overtime as needed.
QUALIFICATIONS AND EXPERIENCE:
- HSD/GED required; Associates degree or bachelor’s degree is preferred. Will accept a minimum of 2 years relevant work experience in lieu of degree.
COMPETENCIES/SKILLS:
- Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
- Legible Handwriting
- Communicate clearly in writing and orally.
- Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4, and Annex 13.
- Demonstrate effective collaboration and teamwork.
- Demonstrate experience working in a cGxP environment.
- Familiar with project management tools and technologies such as Microsoft Project.
- Successfully completes regulatory and job training requirements.
- Computer skills:
- Enter data into computer using software applications for data entry and word processing.
- Work and be proficient with e-mail systems.
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to work with others in a team environment.
SUPERVISORY RESPONSIBILITIES: None
WORK ENVIRONMENT:
Standard office environment
PHYSICAL DEMANDS:
Office Environment (standing and sitting) requiring minimal physical exertion.
TRAVEL:
Domestic travel will be required less than 10% of the time.
If you’re interested in this position, please email careers@expericservices.com with your resume and any relevant documentation, including proof of certifications if specified in the job description.
Be sure to include the position title in the subject line of your email.
We look forward to connecting with you!
The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.
EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.