Manufacturing Specialist

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

• 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.

• High school diploma, GED.
• Some relevant college level STEM courses or training are a plus.

• Bachelors (BA/BS) in Engineering, Chemistry, Biology, Physics.

• 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.
• 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.

• Health insurance
• Health savings account
• Vision insurance
• Flexible spending accounts
• Life insurance

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants:
Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.