Manufacturing Specialist 1

Job Summary: Responsible for technical and process support to the manufacturing team in order to effectively achieve production plans while maintaining quality and compliance to Quality Systems

Tasks and responsibilities:
· Analyze production data to determine trends and define actions to improve efficiency, product quality and cost.
· Identify process discrepancies and collaborate with LCM and Process Engineering for improvement.
· Support maintaining the validated state by providing SME support on Validation plans, verification and validation protocols and executing on released protocols.
· Act as SME during development and change management on MES and eDHR process and systems by collaborating with GIS, Process Engineering and Quality.
· Support development and in some cases create or modify Quality Documents such as; work instructions, procedures, pFMEA’s validation test reports, batch record templates and test methods.
· Proactively participate on continuous improvement teams and projects using techniques from Operational Excellence and Lean Six Sigma methodologies.
· Participate in manufacturing internal audit program and assist with corrective actions and audit responses.
· Test next generation DNA sequencing instrumentation using released procedures and processes.
· Troubleshoot and process non-conformances of products while collaborating with Manufacturing, Quality and Life Cycle Management.
· Establish and maintain reports of instrument failures and defects.
· Other duties as needed.

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

Required educational background:
· High school diploma, GED.
· Some relevant college level STEM courses or training are a plus.

Preferred educational background:
· Bachelors (BA/BS) in Engineering, Chemistry, Biology, Physics.

Preferred experiential background:
· Typically requires no previous technical experience.
· Normally receives detailed instructions on all work.
· Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential.
· Ability to collaborate on multifunctional teams and manage ambiguity.
· Strong interpersonal, verbal and written communication skills.
· Excellent troubleshooting skills required.
· Proficiency with Microsoft Office Tools (Excel, Word, and PowerPoint)
· Experience with SOPs, DHRs, ECOs, GLP, GMP and SAP ERP systems is a plus.
· Hands on experience with clinical/diagnostic instrumentation including DNA sequencing or equivalent is highly desirable.