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Scientist I, Manufacturing

Integrated Resources, Inc

Fremont, CA

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JOB DETAILS
SALARY
$25–$30 Per Hour
SKILLS
Analysis Skills, Background Investigation, Biochemistry, Business Support, Calibration, Chemistry, Cleanroom, Clinical Assessment, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Documentation, Establish Priorities, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Immunoassays, Lift/Move 25 Pounds, Lift/Move 50 Pounds, Maintain Compliance, Manufacturing, Mentoring, Metrics, Operational Improvement, Operational Strategy, Operational Support, Organizational Skills, Physical Demands, Process Improvement, Record Keeping, Regulations, Regulatory Compliance, Safety Process, Safety/Work Safety, Standard Operating Procedures (SOP), Testing, Trend Analysis
LOCATION
Fremont, CA
POSTED
5 days ago
Job Title: Scientist I, Manufacturing
Location: Fremont, CA
Duration: 6 Months+
Pay: $25 to 30/hr. on W2
Shift: Monday to Friday 9am to 5pm

Notes:
May extend or convert after 6 months, based on performance and business needs.

Description: Location/Division Specific Information
Part of Clinical Diagnostics Division of Specialty Diagnostics Group

Client Impactful Work:
  • You will be responsible for manufacturing products for the Bulk Formulations team and complete associated cGMP documentation.
  • You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvements projects.
A day in the Life:
  • Manufacture products including reagents, calibrators, buffers, controls, and intermediates, and complete batch records while maintaining cGMPs and GDP
  • Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release
  • Review of other manufacturing operators/scientist’s batch records
  • Maintain and analyze lot histories for trends and discrepancies
  • Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration
  • Participate in process improvement projects to improve operational efficiencies and support business needs through 5s and lab clean ups
  • Modify SOPs, work instructions, and reports with mentorship
  • Initiate and support investigations for quality documentation including non-conformances, CAPAs, and Variances
  • Maintain and troubleshoot testing and formulations equipment as appropriate
  • Keep department supervisor and/or manager updated on all issues
  • Perform other job duties as the need arises
Keys to Success:
Education
  • BS/BA in Scientific field in Chemistry, Biochemistry, or related technical discipline; equivalent combination of education and years of related experience may be substituted
Experience:
  • 1+ years of related experience and/or training preferred
  • Laboratory skills, including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions
  • Experience in working with potentially hazardous chemicals and human source materials preferred
  • Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
Knowledge, Skills, Abilities:
  • Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
  • Must be organized, detail-oriented, and can prioritize own and other’s work to meet business efficiency metrics
  • Self-sufficient, self-motivated, and focused
Physical Requirements / Work Environment:
  • Controlled Substance Handling: This role involves the handling, management, and oversight of controlled substances. The role will be responsible for ensuring compliance with all relevant regulations and guidelines on controlled substances.
  • Exposure to Controlled Substances: The role may be exposed to controlled substances during their duties. Proper safety protocols and protective measures will be provided and must be strictly followed.
  • Safety Protocols: Ability to adhere to strict safety protocols and procedures to ensure a safe working environment.
  • Background Check: Successful completion of a background check, including screening for any history related to controlled substances.
  • Ability to occasionally lift 50lbs, routinely lift 25lbs


 

About the Company

I

Integrated Resources, Inc