Scientist 1 – Formulation

PDS Tech, Inc.
Published
February 9, 2021
Location
Fremont, CA
Category
Job Type

Description

PDS Tech is seeking candidates for a Scientist position in Fremont, CA

How will you make an impact?

The Scientist I, Formulations is responsible for manufacturing products for the Bulk Formulations team and completes associated cGMP documentation. Works with chemicals and biologicals to manufacture reagents, calibrators and controls for IVD use. Participates in process improvement projects.

What will you do?                                         

  • Manufacture reagents and buffers following cGMPS
  • Perform in-process testing using clinical analyzers. Review and analyze data.
  • Review other manufacturing operators/scientist’s batch records.
  • Maintain and analyzes lot histories for trends and discrepancies.
  • Weigh, transfer, and mix required chemicals
  • Perform product filtrations
  • Participate in process improvement projects to improve efficiencies and support business needs.
  • May modify SOPs, work instructions and reports with guidance.
  • Initiate and support investigations for NCARS, CAPAs, and Variances
  • Maintain and troubleshoot equipment as appropriate.
  • Keep department supervisor and/or manager updated on all issues
  • Perform other job duties as required

How will you get here?

  • BS/BA in scientific discipline (Chemistry or Biochemistry preferred) with 0-2 years related experience and/or training preferred. Equivalent combination of education and years of related experience may be substituted
  • Experience in working with potentially hazardous chemicals and human source materials is a plus
  • Laboratory skills and knowledge of safety precautions  is a plus
  • IVD manufacturing experience is a plus

Knowledge, Skills, Abilities

  • Laboratory skills and knowledge of safety precautions  is a plus
  • Familiarity with Quality System Regulations and ISO 13485 regulations is a plus
  • Must perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations
  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling
  • Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics
  • Self-sufficient, self-motivated, and focused
  • Must be able to lift 25 lbs routinely

PDS Tech, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:

  • Health insurance
  • Paid holidays
  • Weekly payroll
  • Immediate 401(k) eligibility
  • Completion Bonuses
  • Training
  • Please note availability of benefits may vary by position

PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit www.pdstech.com

$$$ PDS pays for referrals! $$$

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