Specialist Manufacturing 35209

Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative shift

Description:

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.

Competencies / Skills:

1. Experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
2. Proficient and experienced in owning Change Controls.
3. 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.
4. Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
5. Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.
6. Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
7. Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
8. Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
9. Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system.
10. Experience navigating and executing transaction in SAP (ERP) system.
11. Ability to tactfully negotiate and positively influence peers and executive leadership.
12. Strong negotiation skills when working with external suppliers and internal team members.

Responsibilities:

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Responsible for managing NC/CAPA closure within established goal.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with generation of process validation protocols and reports.
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assist manufacturing change owner on CCRB packages impacting the process.

Education:

Bachelor's degree and 5 years of Manufacturing Operations experience or associate’s degree and 10 years of Manufacturing Operations experience