Perform several manufacturing functions within the operation manufacturing team. All shifts are available, must be okay with working on weekends.
ESSENTIAL JOB RESPONSIBILITIES:
- Understand and adhere to safety policies and practices
- Follow Dry Room Procedures
- Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR)
- Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions.
- Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures.
- Set up and operate manufacturing equipment.
- Clean and maintain equipment and work area.
- Work under close supervision
- Assist Senior Operators
- Use tools such as microscopes, tweezers, and other hand-held tools.
- Perform in-process inspection of components and assemblies to verify quality conformance.
- Recognize any minor issues from the equipment and any affiliated documentations and take appropriate corrective action within scope. Notify Supervisors and Leads of issues and discrepancies immediately.
- Report causes of process and/or documentation and assists or coordinate resolutions.
- Perform several Manufacturing operations proficiently.
- Apply company policies and procedures to complete assignments.
- Conduct Shift PASSDOWN with peers
- Follow production schedules
- Follow acceptance criteria for equipment yield and efficiency
- Monitor machines and informs Supervisor and Lead of problems.
- Start and end batch runs
- Email the Manufacturing Engineering group explaining any downtime problems/issues.
- Perform label printing responsibilities
- Review DHRs
- Prepare and verify materials to be used as issued to work orders
Education or Experience (in years):
1-2 years of related experience
High School diploma/GED or equivalent experience
Experience in clean room assembly or Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience.
Experience in FDA or Kema audits
Knowledge and skills:
Knows how to read drawings.
Understands Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
Must be a team player and able to demonstrate willingness and ability to provide assistance to co-workers.
Ability to clearly and effectively communicate with peers, supervisors, manufacturing engineers, stockroom managers and leads. Able to understand instructions and batch records written and spoken in English.
Effective verbal and written communication skills
Ability to pay close attention to detail.
Basic Computer Skills
Ability to solve basic math problems
Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.
Ability to work directly with, handle or come into contact with chemicals or reagents.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.