Ref No.: 18-01050
Location: Fremont, California
Position Type:Contract
Start Date: 02/05/2018
Job Category:Non-IT Scientific/ Clinical
Key Responsibilities:
  • Manufacture bulk products and perform testing using chemistry clinical analyzers
  • Completes manufacturing batch records and MPIs, ensure compliance at all times in accordance with cGMP including GDP
  • Meet on-time delivery dates for each assigned work order and adhere to production schedule
  • Review and analyze data
  • Weighing, transfer, mixing of chemicals required
  • Initiates non-conformance reports as required
  • Perform product filtrations
  • Review and approve completed batch records
  • Maintain and analyze lot histories for trends and discrepancies
  • Assist with modifying SOPs, work instructions and reports
  • Recommends improvements to processes, environment or equipment
  • Participate in daily/weekly lab '5s' activities
  • Keep department lead or manager updated on all issues
  • Monitor stocks of common lab supplies
  • Perform other job duties as required.
Minimum Requirements/Qualifications:
  • BS/BA in scientific discipline (chemistry/biochemistry) with 0 - 2 years related experience and/or training preferred. AA degree with 2 - 4 years related experience may be substituted
  • Experience/understanding of Quality System Regulations and cGMP preferred
  • Detail oriented, organized, self-motivated and focused
  • Good verbal and written communication skills
  • Can follow procedures carefully
  • Computer/software skills (Outlook, Excel and Word)
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
Non-Negotiable Hiring Criteria:
  • Basic lab skills and knowledge of safety precautions
  • Must be able to work with potentially hazardous chemicals and human source materials
  • Must be able to walk and/or stand for extended periods of time
  • Must be able to lift 25 lbs routinely.
  • May be required to lift up to 50 lbs occasionally.