Manufacturing Specialist 3

Position Summary:

We are seeking a highly motivated and self-driven individual with experience in analytical testing, in addition to contributing with daily production schedule in order to effectively achieve production plans while maintaining the highest quality within compliance and FDA regulations.

Responsibilities:

• Function as a Lead Water Spider and be aware of teammates activities and prevent potential issues

• Perform and explain, teach, & promote all aspects of our training program manufacturing operations and sign off on OJTs (On the Job Training forms)

• Perform Analytical testing on reagents and serve as a SME for assay troubleshooting

• Create a daily schedule of work assignments for production personnel

• Monitor production outputs to make sure it meets all specifications with engineering team and scheduling needs with planning

• May track and trend data for use of continuous improvement for consumables production lines related to yield, quality and throughput

• Actively contribute to team discussion, project planning and project execution

• Maintain an organized, safe and efficient work area at all times (6S)

• Identify process discrepancies, resolve technical issues and improve procedures

• Participate as SME in cross-functional events such as RIEs

• Expert knowledge of each process for which the incumbent is directly or indirectly responsible. Considered the subject matter expert (SME).

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• Experience in analytical testing is preferred

• Experience in Training is preferred

• Experience with SAP and Camstar is a significant plus

• Experience with Non-Conformance Report is highly preferred

• Accurate and timely data evaluation skills and attention to detail

• Team oriented with excellent communication skills

• Excellent cross-functional collaboration

• Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) and outlook is plus

• Ability to apply medical device quality system requirements (21 CFR 820, ISO 13485, etc.) to manufacturing processes and documentation is required

• Familiarity with standard laboratory practices

• Demonstrated chemistry, math and analytical skills required

• Knowledge of molecular biology techniques; SNP genotyping is a plus

• Strong interpersonal, verbal and written communication skills required

• Must be very detail oriented

• Experience with lean manufacturing tools and principles a plus

• Familiarity with Six Sigma is a plus

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Experience/Education:

• Typically requires a bachelor’s degree and 4 to 6 years of related experience

• Related Master’s Degree with 2 to 4 years of industry experience

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