Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill Client requirements to implement supplier changes. Applicant must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

1. Perform investigations, using Infinity system, for Supplier Complaints including but not limited to Client and Supplier’s processes.
2. Create and execute Corrective Actions and Preventive Actions (CAPA)
3. Prepares, submit and discuss finding of the investigation process with key stakeholders.
4. Perform trending analysis of site events and complaints. Investigate and root-cause “no-fault found” investigations and implement internal process improvements to prevent reoccurrence.
5. Generates, reviews and implements procedure and forms to assure compliance with current practices or GMP trends.
6. Provides support to the supplier development team preparing quarterly data for Quality Council and governance meetings.
7. Evaluates and improves supplier complaint investigation and material return process.
8. Creates, evaluates, follows up and approves Change controls for the Devens site, including interaction with corporate support areas, other Client sites and third parties.
9. Ensures Change controls are created according to local SOPs and corporate directives with all the appropriate requirements in placed for each change control, monitor and ensure actions are implemented and closed on time and status up-dated in related quality system. Inform supervisor or site procurement lead in case of issues.
10. Create detailed plans of the activities using Project Management tools.
11. Provides support, training and development to the suppliers and internaly to avoid Client and Suppliers issues recurrence.
12. Implements processes and procedures to address supplier performance deficiencies.
13. Ensure compliance with corporate and site procedures, cGMPs regulations and other industry guidelines.
14. Apply Lean Six Sigma tools to reduce investigations establishing proper corrective, preventive and proactive actions.
15. Manages and executes supplier program for the investigation and resolution of deviations, CAPA, and complaints.
16. Provides oversight of suppliers preforming investigations, change controls, protocols and reports in support of Client products.
17. Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure

Requirements:
• Bachelor’s Degree in Business, Science or Industrial Engineering
• Six (6) years of experience in Quality, Purchasing, or Manufacturing Technology (Technical Services) experience within a manufacturing pharmaceutical industry.
• MS/MBA/CPIM/ASQ/Lean Manufacturing/Procurement experience is a plus.
• At least 3 years handling investigations process
• At least 3 years handling change control process
• Must have proven track record of successfully managing projects, and responsible for developing & implementing quality processes in a pharmaceutical environment.
• Strong customer service orientation with excellent analytic, interpersonal, communication and negotiating skills
• Proactive, creative and analytic approach.
• Strong understanding of supplier development & supplier quality experience is a must.
• Short-term execution and long-term strategic thinking capabilities, ability to multitask with a sense of urgency.
• Ability to interface with external resources and internal resources at all levels.
• Demonstrated hands on supplier management implementation in FDA regulated businesses.
• Ability to communicate effectively within a matrix organization.
• Effective at selling ideas, services and solutions to others at different organizational levels and functions.
• Demonstrates leadership, interpersonal, communication, and motivation skills
• Excellent writing and oral communication skills are required.

How to Apply

Job Types: Temporary.

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