Scientist-I

1.1. Works under the direction of the Quality Assurance Organization and is responsible for providing support and leadership to the QA Team and the Sterilization Dose Audit Program to achieve quality, efficiency, and cost targets, while ensuring compliance to all applicable standards.

2. EDUCATION/CERTIFICATION REQUIREMENTS:

2.1. High school diploma or equivalent required.

2.2. University/Bachelor’s Degree or equivalent required, Microbiology preferred.

2.3. Six-sigma certification preferred.

3. KEY SKILLS/KNOWLEDGE REQUIRED:

3.1. SKILL SETS

3.1.1. General knowledge of medical devices preferred.

3.1.2. Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.

3.2. COMPUTER SKILLS

3.3. EXPERIENCE

3.3.1. One or more years in microbiological laboratory environment or equivalent training.

3.3.2. One or more years in project management preferred.

4. KEY JOB RESPONSIBILITIES:

4.1. Provide leadership and execution for Sample Item Portions (SIP s) preparation, testing, documentation, reporting, and conclusions.

4.2. Provide leadership and execution for Environmental Monitoring Program (EM) for the Albuquerque Facility.

4.3. Provide leadership of activities and serve as a resource for quality issues and initiatives.

4.4. Provide coaching and mentoring of QA Technicians under the direction of the Quality Assurance Organization.

4.5. Coordinate with Manufacturing Operations to schedule and retrieve audit product samples on a timely manner.

4.6. Perform physical manipulation of product into SIP s under aseptic conditions.

4.7. Aseptically package and ship SIP s to testing laboratories.

4.8. Maintain Laboratory equipment and supplies for SIP s and EM.

4.9. Maintain accurate records verifying that required samples have been collected, processed and dispersed to appropriate testing laboratories.

4.10. Reviewing the incoming data for completeness and adherence to specifications.

4.11. Maintain communication links between different testing laboratories to ensure timely testing and accuracy of samples.

4.12. Create and Maintain laboratory procedures and governing documents.

4.13. Environmental

4.13.1. Participate in implementation of the EMS management system including continual improvement, pollution prevention, objectives and targets, and regulatory compliance.

4.13.2. Implement and follow all applicable EMS procedures.

4.13.3. Adhere to the site’s EHS Code of Conduct.

4.14. Other responsibilities may be assigned and not all responsibilities listed may be assigned.

5. POST HIRE TRAINING PLAN REQUIREMENTS:

5.1. Maintain adherence to position training curriculum.

5.2. Training Plan Requirements as identified in Corporate Training Procedure, CP0128.

5.3. Applicable training plan for the area of support.

6. PHYSICAL DEMANDS:

6.1. Requires long walking, standing, bending, stooping and reaching.

6.2. May require lifting of boxes or material not to exceed 50 lbs.

6.3. May require use of a pallet jack.

6.4. Maintain vision certification through the visual acuity testing/process.

6.5. Office deskwork, requiring sitting, walking, using the phone and computer

6.6. Operation of hydraulic and manual cutting equipment daily.

7. WORK ENVIRONMENT:

7.1. Work in office and/or manufacturing environment and/or laboratory environment.

7.2. Flexibility to adjust and rotate the working hours to support Laboratory needs.

7.3. Gowning required as per established procedures.

EDUCATION/CERTIFICATION REQUIREMENTS:

2.1. High school diploma or equivalent required.

2.2. University/Bachelor’s Degree or equivalent required, Microbiology preferred.

2.3. Six-sigma certification preferred.

For more information, Please contact

Sneha Shrivastava

(973) 967-3348