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MFG Sr Associate-Filling & Visual Inspection

Lancesoft

Fremont, CA

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JOB DETAILS
SKILLS
Asepsis, Cleanroom, Corporate Policies, Current Good Manufacturing Practice (cGMP), Data Entry, Datasheets, Documentation, Environmental Monitoring, Environmental Protection Agency (EPA), Federal Laws and Regulations, GMP (Good Manufacturing Practices), Hand Tools, Hazardous Materials Clean-Up, Hazardous Materials/Substances, High School Diploma, Housekeeping/Cleaning, Identify Issues, Inkjet Printers, Leadership, OSHA, Procedure Development, Production Schedule, Quality Control, Safety Process, Safety/Work Safety, Simulation, Staff Training, Standard Operating Procedures (SOP), State Laws and Regulations, Sterilization, Team Player, Testing, United States Department of Agriculture (USDA)
LOCATION
Fremont, CA
POSTED
28 days ago
Title: MFG Sr Associate-Filling & Visual Inspection
Pay Rate: $40.00 44.81/hr on W2
Location:Fremont, CA 94555
Duration: 06 Months
Shift: 3rd Shift: Sun-Thurs-10 PM-6: 30 AM

Job Description:
Job Duties:
  • Ability to independently and accurately prepare all assigned records, calculations, and documentation.
  • Demonstrated ability to independently and properly handle and dispose of hazardous waste.
  • Ability to read and follow schedules, procedures, and documents.
  • Demonstrated knowledge of safety precautions and procedures.
  • Will be required to assist in training other employees in an area of responsibility as assigned.
  • Assist staff in developing new procedures and methods or improving old ones.
  • Ability to practice aseptic techniques independently.
  • Ability to perform media fills with (process simulation testing) with passing results per applicable SOP.
  • Ability to perform clean room gowning and pass clean room garment validation consecutively.
  • Ability to independently prepare disinfectants and sanitizing solutions.
  • Ability to independently clean and sanitize production equipment, rooms and areas.
  • Demonstrated knowledge of an aseptic operation and the relationship of laminar flow systems and environmental monitoring.
  • Ability to assist in performing environmental monitoring, such as but not limited to, independently placing settling plates and air sampling.
  • Ability to use basic hand tools.
  • Ability to independently set-up, operate, maintain and troubleshoot steam sterilizers, capping machines, stoppering machines, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, L bar sealers/Bundler, vision systems, inkjets, vacuum check equipment as needed.
  • Ability to wear a respirator if required of the job, no pulmonary restrictions.
  • Ability to independently use and understand computer assisted data entry.
  • Ability to independently perform sterile filtration.
  • Ability to aseptically gather and transfer samples for QC testing.
  • Ability to independently perform filter integrity and prepare accurate documentation

Skills:
  • Experience with GMP production
  • Direct & relevant experience with Aseptic processing/filling.
  • Experience with:
  • Document Revision
  • Deviation Management
  • Production coordination/scheduling
  • Demonstrated knowledge of:
  • Federal, State, and international regulations, such as cGMP, USDA, DOT, EPA, OSHA
  • Corporate guidelines and Policies related to the employee s work.
  • Standard Operating Procedures (SOPs)
  • Material Safety Data Sheets (MSDSs), safety procedures, and hazardous materials procedures.
  • Aseptic processing procedures related to the employee s work.
  • Team process and leadership principles.
  • Appropriate processes and theory related to the employee s work.
  • Documentation related to the employee s work.
  • Equipment as defined in Duties Additional education and/or equivalent experience.
  • Successful completion of National Career Readiness Work Keys assessment.
  • Traffic Patterns.
  • Working with BPE Methods.
  • Understanding of Basic GMP/Documentation practices.
  • Ability and understanding of safe working habits.
  • Ability to work in a team environment.

Education:
  • High School diploma or Client
Years of experience: 2

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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