Vacancy expired!
Clinical Supplies Specialist Rahway, NJ Must be local to PA/NJ. Hybrid working model (Remote + Onsite). Project Description:
- This role includes batch documentation review to ensure our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions.
- Areas of focus revolve around packaging, labeling and distribution activities.
- In addition, associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.
- 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, coordination of clinical quarantine and recovery actions.
- Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement, and cross-functional team building.
- Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution 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 outcomes, 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.
- Clinical Document/labeling/packaging Batch review of CMO & the Client's site materials.
- Candidate will also review regulatory/filing submissions.
- At least a bachelor's degree with a technical emphasis in an appropriate scientific or engineering field preferred.
- Minimum of 5-7 years' post-degree experience in the Pharmaceutical or equivalent industry (clinical packaging/labeling/inspection of vaccine, biologics, pharmaceutical oral dosage, controlled substance, or Investigation Medicinal Product (IMP) packaged into Finished Kits Goods for clinical trials NO food preparation/makeup/beauty).
- Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality Operations or DEA.
- Clinical manufacturing background.
- Not looking for commercial background.
- Familiarity with batch disposition (release) activities and GMP clinical batch record review of packaging and labeling are a strongly preferred skills necessary for success in this position; prior batch disposition experience and regulatory review submission are 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.
- Previous experience with on the floor Q/A, process improvement.
- Does not want to see candidates with lab skills.
- Effectiveness and creativity in approaching and solving technical problems.
- In-depth working knowledge of current Good Manufacturing Practices (cGMPs) and of regulatory requirements as they apply to the pharmaceutical field or a related area.
- Basic understanding of the use and maintenance for Microsoft 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.
- Change Control and CAPA.
- Required Computer skills; knowledge and competency in Track Wise, SAP ECC (product disposition & electronic batch records/release of materials), Electronic Document Systems (i.e., Veeva, MIDAS, Qumas, Documentum, etc.) PowerPoint, Excel, OneNote, and Word.
- Ability to independently manage multiple priorities.
- Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma and Project Management.
- ID: #23463270
- State: New Jersey Rahway 07065 Rahway USA
- City: Rahway
- Salary: BASED ON EXPERIENCE
- Job type: Contract
- Showed: 2021-11-25
- Deadline: 2022-01-23
- Category: Science/biotech