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Job Summary
The Manufacturing Process Support Specialist is responsible for providing technical and process support to the manufacturing team to ensure production goals are met while maintaining high standards of quality and compliance. This role involves analyzing production data, supporting validation activities, and collaborating across departments to drive continuous improvement in manufacturing processes.
Job Summary
The Manufacturing Process Support Specialist is responsible for providing technical and process support to the manufacturing team to ensure production goals are met while maintaining high standards of quality and compliance. This role involves analyzing production data, supporting validation activities, and collaborating across departments to drive continuous improvement in manufacturing processes.
Key Responsibilities
- Provide technical and process support to manufacturing operations to effectively achieve production plans while ensuring quality and compliance with internal quality systems.
- Analyze production data to identify trends and define actions that improve efficiency, product quality, and cost-effectiveness.
- Identify process discrepancies and collaborate with Life Cycle Management (LCM) and Process Engineering teams to implement improvements.
- Support the validated state of manufacturing processes by contributing to validation plans, verification and validation protocols, and executing released protocols.
- Act as a subject matter expert (SME) during development and change management activities related to Manufacturing Execution Systems (MES) and electronic Device History Records (eDHR), in collaboration with GIS, Process Engineering, and Quality teams.
- Assist in the development, modification, and maintenance of quality documents such as work instructions, procedures, process Failure Modes and Effects Analyses (pFMEAs), validation test reports, batch record templates, and test methods.
- Participate in continuous improvement initiatives using Operational Excellence and Lean Six Sigma methodologies.
- Contribute to the internal manufacturing audit program and assist with corrective actions and audit responses.
- Perform testing of next-generation DNA sequencing instrumentation using established procedures and processes.
- Troubleshoot and resolve product non-conformances in collaboration with Manufacturing, Quality, and LCM teams.
- Maintain detailed reports on instrument failures and product defects.
- Perform other duties as assigned.
Required Skills
- Knowledge of validation processes and quality control in a regulated manufacturing environment.
- Understanding of Good Manufacturing Practices (GMP).
- Strong analytical and problem-solving skills.
- Effective communication and collaboration abilities.
Preferred Qualifications
- Bachelor’s degree (BA/BS) in Engineering, Chemistry, Biology, Physics, or a related scientific discipline.
- Familiarity with MES and eDHR systems.
- Exposure to Lean Six Sigma or other continuous improvement methodologies.
Pay And Benefits
The pay range for this position is $26.00 - $32.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
Available For This Temporary Role May Include The Following
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Hayward,CA.
Application Deadline
This position is anticipated to close on Jun 24, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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