Quality Specialist - I (Assistant)
126 E Lincoln Ave Rahway, NJ 07065 US
Target PR Range: 30-40/hr
*Depending on experience
• This position reports to the Associate Director of Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via supporting disposition activities for clinical finished goods provided by our Company for worldwide clinical trials.
• Specifically, this includes direct support for batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (GMP) regulations and relevant regulatory filing submissions.
• Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types to support clinical protocols as well as Managed Access Programmes, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.
Responsibilities may include, but are not limited to, the following:
• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable. Policies/procedures of our Company and compliance with all governing regulations.
• Coordinate and/or support the preparation of procedures, processes and quality improvements.
• Assists in the coordination of significant quality events including fact-finding, investigation support, and coordination of clinical quarantine and recovery actions.
• Collaboration across Integrated Process Team (IPT) functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.
• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.
• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans, when possible.
• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem solving and day-to-day operational activities.
Education Minimum Requirements:
• Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred.
Required Experience and Skills:
• Minimum of two years' post-degree experience in the Pharmaceutical or equivalent industry (GMP related field) including Technical, Engineering, Quality or Operations.
• Effectiveness and creativity in approaching and solving technical problems.
• In-depth working knowledge of current Good Manufacturing Practices and of regulatory requirements as they apply to the pharmaceutical field or a related area.
• Basic understanding of the use and maintenance for Microsoft (MS) applications (such as MS Excel, Outlook, and/or MS Access).
• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Demonstrated teamwork skills and ability to work independently.
• Attention to detail, flexibility and an awareness of production and quality control problems.
Preferred Experience and Skills/Nice to haves:
• Familiarity with batch disposition (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus.
• Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs) is a plus and a strongly preferred skill.
• Previous experience in quality control, quality assurance, auditing or regulatory affairs.
• Ability to independently manage multiple priorities and projects.
• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.
• Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma and Project Management.
• Computer skills; knowledge and competency in Enterprise Resource Planning (ERP)/Manufacturing Execution Systems (MES), Trackwise, SAP, PowerPoint, Excel and Word.
*NOTE*: Hybrid role- Required to come 2-3times/week-Onsite. M-F(8a-5p), 40hrs/week.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.