Manufacturing Specialist 33169 - 1892423

🌟 Title: Specialist Manufacturing (Medical Device Supply) 33169 🌟

🌐 Location: Hybrid/Virtual/Remote work (Must be resident in Puerto Rico)

⏰ Shift: Administrative: Monday - Friday 8am – 5pm (exceptions possible for supporting manufacturing plants outside our time zone)

Opportunity: (1)

Period: Approximately one year

SUMMARY:

🚀 With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Preferred Qualifications:

✨ Project Management and/or Quality Management skills and experience.

🌟 Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.

🌈 Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.

🛠️ Experience managing quality records (deviations (major and minor), CAPAs, CAPA-EV, Change Controls) using TrackWise System.

📊 Experience navigating and executing transactions in SAP (ERP) system.

💼 Experience managing suppliers. Strong negotiation skills when working with external suppliers and internal team members.

🖥️ Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook).

📝 Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.

🌐 Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work, and communicate effectively.

🔍 Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.

EDUCATION/LICENSES:

🎓 Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience OR Associate’s degree and 10 years of Manufacturing Operations experience OR High school diploma / GED and 12 years of Manufacturing Operations experience.

FUNCTIONS:

Applied Process Expertise

1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
3. Provide troubleshooting support.
4. Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Process Monitoring

1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
2. Provide support for timely execution of the process monitoring quarterly reports.

Non-Conformance and CAPA

1. Ensure that all Non-conformances are triaged within the established goal.
2. Responsible for authoring investigation reports.
3. Responsible for the execution of corrective actions.
4. Responsible for managing NC/CAPA closure within the established goal.
5. Monitor and communicate incident trends.
6. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation

1. Assist with the generation of process validation protocols and reports.
2. Assist with the execution of the process validation.
3. Support the collection and analysis of process validation data.

Regulatory

1. May participate in regulatory inspections.

New Product Introductions & Process or Equipment Modifications

1. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control

1. Assist manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives

1. Participate in the assessment or implementation of special projects or initiatives.

Other functions may be assigned.

COMPETENCIES/SKILLS:

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in the performance of GMP production operations.
• Regulatory knowledge and interactions.
• Participate and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Ready to make an impact in the dynamic world of medical device manufacturing? Send us your updated resume at careers@proqiualitynet.com with the subject line: Specialist Manufacturing 33158, and let's build the future together! 🌟