Description:
CAPA/NCR writers
12 months contract; May extend
Onsite
Essential Duties and Responsibilities:
1. Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
2. Execute implementation of CAPAs associated with NCR investigations.
3. 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 Baxter corporate quality requirements.
4. Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.
Qualifications:
1. Candidate must not be allergic to Penicillins or Cephalosporins
2. Understanding of the product’s intended use and manufacturing process
3. Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
4. Strong problem solving and analytical skills.
5. Consultation and facilitation skills.
6. Understanding of statistics in support of fact based decision making.
7. Excellent written/verbal communication and organizational skills
8. Ability to make independent decisions with minimum oversight
9. Customer sensitivity / acumen and ability to interact with all levels of management.
10. Experienced user of TrackWise preferred.
11. Working knowledge of FDA Regulations and International Regulatory requirements.
12. Understanding of risk management tools.
13. Available to work during off-shift or weekends as appropriate to support investigations and training
Education and/or Experience:
• 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.
...annual continuing education reimbursement (full-time staff)~ Flexible scheduling - full & part-time opportunities ~ Ethical workplace and a... ...and personally ~ Competitive salary ~ Health, dental, and vision insurance ~ Company-paid life insurance ~401k matching...
...Our esteemed client is seeking a highly motivated Analyst or Associate to join their investment team. This is an excellent opportunity for a finance professional... .... ~23 years of relevant experience in investment banking, corporate finance, or similar fields. ~ Strong...
...Electrical Engineer (23 Years Experience) We are seeking a motivated Electrical Engineer with 23 years of experience in electrical design to join our growing team. The ideal candidate has hands-on experience with electrical system layouts for commercial or industrial...
Stratejic Relationships is looking for a detail-oriented Remote Data Entry Clerk to join our team. This position offers the flexibility of working remotely while ensuring the accuracy and efficiency of data management processes critical to our success. Key Responsibilities...
Company Description Carlyle Avenue is an online resource for chic and affordable home goods, dedicated to providing unique and fashionable decorative accessories. Our easy-to-navigate online boutique brings high-quality style directly to your doorstep, featuring a range...