What are the responsibilities and job description for the Operations Planner position at Kelly?
Position Title: Operations Planner II
Reports to: Manager, Integrated Clinical Programs
Basic Responsibilities:
Level 2: Responsible for independently coordinating all activities associated with timely packaging, labeling and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies. This individual is responsible for timely execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress and review of documentation and procedures.
Duties and Responsibilities (including but not limited to):
- Provides input and partners with Supply Chain stakeholders to develop the packaging/labeling strategy for Clinical Supplies Specifications.
- Ensures all clinical supplies are processed according to cGMPs and appropriate safety requirements to meet existing standards defined by the FDA and EU or other international regulatory agencies.
- Fully familiar with the SAP system and skilled user of such application. Utilizes computerized inventory and other special applications and tools as necessary for production of all packaging and labeling documentation. Capable of running reports and ad hoc queries to support the business.
- Be capable to act as an approver of packaging and/or labeling documentation.
- Prepares and processes documentation in accordance with study requirements.
- Ensures all processes are covered by Standard Operating Procedures through contributing to or authoring within their functional area.
- Contributes to packaging, labeling and distribution strategy through participation in process and approval of proposals.
- Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies and participates in adjustment of logistics pertaining to drug supply. May involve liaison with other cross functional stakeholders.
- Investigate and document deviations that may occur.
- Could represent the Operations group on internal teams as appropriate. Will undertake specific projects within the group on an as-needed basis.
Education and Work Experience:
- Bachelor's degree in life science, engineering or business (required) and at least 3 years experience in the pharmaceutical industry, preferably in a clinical supply related area.
Knowledge, Skills and Abilities:
- Problem solving skills, including ability to think critically in addressing issues such as investigations and complaints.
- Detail-orientated.
- Interpersonal skills in verbal and written communication, ability to negotiate, resolve conflicts and engage in decision making to partner and influence.
- Excellent computer skills including Microsoft applications; SAP is highly desirable.
- Proven organization skills.
- Strong ability to multi-task.
- Ability to follow Standard Operating Procedures (SOP's).
- Demonstrated high level of initiative and ability to function independently with minimal or no daily supervision.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly®?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
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