Details: Stefanini Group is hiring! Stefanini is looking for CAPA Writer in Round Lake, ILFor quick Apply, please reach out to Vipul Bhardwaj – call: 2482638630/ email: vipul.bhardwaj@stefanini.comWork Hours: M-F (40 hours)Work Location: Round Lake, ILShift: 1st Shift
- Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
- Execute implementation of CAPAs associated with NCR investigations.
- Maintains a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements. Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and corporate quality requirements.
- Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.
Job Requirements Details: Job Requirements:
- BS/BA (4 years of university level education) in science, engineering or related field.
- 2-4 years relevant work experience in cGMP related industry or in a clinical setting.
- Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plus.
- Candidate must not be allergic to Penicillins or Cephalosporins
- Understanding of the product’s intended use and manufacturing process
- Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
- Strong problem solving and analytical skills.
- Consultation and facilitation skills.
- Understanding of statistics in support of fact based decision making.
- Excellent written/verbal communication and organizational skills
- Ability to make independent decisions with minimum oversight
- Customer sensitivity / acumen and ability to interact with all levels of management.
- Experienced user of TrackWise preferred.
- Working knowledge of FDA Regulations and International Regulatory requirements.
- Understanding of risk management tools.
- Available to work during off-shift or weekends as appropriate to support investigations and training
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.About Stefanini GroupThe Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.#LI-VB1#LI-ONSITEPay Range: $ 60.00 – $ 65.00
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