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.
...needs of your dedicated on-site hiring manager. We pride ourselves on our sense of urgency and our ability to drive results. No experience necessary; we will set you up for success with our best-in-class paid training program. Whats in it for you: ~$45,000 per...
...Environmental, Health & Safety (EHS) Manager SAVI EHS Aldie, VA (On-Site) Compensation: $45.00 $50.00 per hour Local candidates... ..., and risk mitigation techniques ~ Proficiency in Microsoft Office and digital safety reporting tools ~ Exceptional communication...
...the peers they work with? Welcome to Zensar! Read on for more details on the role and about us. What's this role about? looking... ...-led quality practices. QA / Quality Engineering Delivery Manager Location: Secaucus , NJ. Role Overview We are looking...
...company code setup This position is Remote, with occasional travel to Phoenix, AZ Responsibilities : Program Leadership... ...accountable ~ Bachelors Degree is preferred; equivalent real-world work experience will be considered ~ CSM/CSPO/PMP Certifications...
Summary of Responsibilities A Behavioral Health Practitioner (BHP) works under the direction and supervision of a Clinical Manager, providing community-based behavioral health services to individuals with psychiatric illness, substance use issues and/or co-occurring disorders...