Manufacturing Specialist 1
25861 Industrial Boulevard Hayward, CA 94545 US
Job Description
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 Client 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 pFMEAas 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.
**salary will be commensurate with experience**
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Hayward, CA
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
