Category: Scientific & Clinical
Title: Packaging Documentation Lead
Location: East Windsor, NJ
Duration: Direct Hire
Schedule: M-F First Shift
Target Start Date: ASAP
- Gathering Data for packaging deviation investigation, performance of Root Cause Analysis to determine the most likely cause of the deviation, assessment of event for product/process impact, perform trending analysis.
- Identification and Execution of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
- Change Control Initiation and Executions to changes deriving from investigation and/or standalone changes.
- Accurately capture immediate actions and containment of the event, address comments from both internal and external audits on the compiled final report.
- Complete the packaging investigations on time.
- Prepare new SOP”s , revision of existing SOP’s and training of packaging operators on SOP’s.
- Works proactively in addressing potential issues and applies real-time problem solving skills when working towards resolution.
- Provides regular and timely reports and interpretation of results to the Packaging Manager.
- Review of packaging batch record as required.
- Follow company policies, cGMP’s and Standard Operating Procedures.
- Perform any and all additional tasks relating to the operation of the packaging department as requested.
- 40% Daily To investigate incidents and complete investigation within the time limits of procedures. To prepare the packaging documents according to procedures and complete it on time.
- 20% Daily Execute and track CAPAs and Change Controls.
- 20% Daily To Prepare the Sop’s for new equipment and revise it whenever required. To prepare change controls whenever required and complete it on time.
- 20% Daily Training Packaging Employees based on conclusion of Investigation, CAPA & Change Control.
- BS e.g. Bachelor of Science.
- Up to 6 years of work experience in a pharmaceutical packaging environment with proven technical writing skills.
- The ability to effectively build and maintain relationships and motivate a highly diverse team in order to effectively negotiate and solve problems.
- Ability to investigate issues, analyze root causes and define resolutions.
- The ability to facilitate and generate the exchange of ideas to resolve problems, select and prioritize optimal solutions and implement decisions.
- The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
- The ability to maintain an attention to detail while executing multiple tasks.
- The ability to exhibit flexible thinking.
- A continuous improvement and quality mindset.
- A willingness to develop yourself and others.
- Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, DEA regulations and/or MSDS.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.