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.
...Company Description CPS Outdoors specializes in designing and building high-quality custom pools and outdoor spaces that combine style, functionality, and durability. By focusing on delivering exceptional craftsmanship, the company creates unique environments that...
...Job Description Aramark Healthcare+ is seeking candidates for a Coffee Shop Manager position to oversee specialty coffee dining and assist with other retail operations at Chestnut Hill Hospital, located in Philadelphia, PA. This is a management position, responsible...
...Kubernetes Location: Houston, TX (Hybrid Day 1 Onsite) Experience: 12+ Years Domain: Oil & Gas / Industrial IoT Engagement: Long-term... ...or advanced industrial analytics Prior work in refinery, upstream, midstream, or downstream operations Azure...
...SENIOR ESTIMATOR JOB ID: 24067 LOCATION: Richland, MS Our client is looking for a Senior Estimator who will lead cost estimating for large electrical infrastructure projects. Youll prepare competitive bids, mentor junior estimators, and collaborate with project...
...client, a home manufacturing company, is seeking a talented Bedding Designer to join their creative team. This role is perfect for someone... ...with Sourcing and Merchandising to ensure alignment with brand and customer design direction Stay current with trends through...