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Senior QC Analyst

Ascent

Job Description

19-04737 / Senior QC Analyst
Location: Emeryville, CA (Local candidates Only!)
Industry: Biotechnology / Pharma
Type: Quality Control: Testing
Level: 3 years of professional GMP testing experience.
 
Bay Area residents, who submit a cover letter prioritized!
 
Summary of job:
Use experience in all analytical assay method training to coordinate & perform critical material qualification & maintenance and/or other projects that are in addition to typical release, reference/reagent qualification and/or stability testing.

Must Haves:
  • At least 1-3 years' experience in a regulated GMP testing laboratory
  • Proficient in MS Word, MS PowerPoint & MS Excel software
  • Must be familiar with GMP's & Quality System Regulations (QS Regs)
  • Must have good time management, effectively prioritizing tasks for completio
  • Must have substantial (3 or more) assay testing experience in one of the main areas listed below:
  • Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's & in vitro diagnostic test kits.
  • Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing & Growth Promotion.
  • Bacterial & Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity & phenotype testing, DNA Plasmid isolation & restriction digest testing.
  • Environmental/Utility/facility Monitoring testing such as Sampling of & testing of manufacturing water by membrane filtration, viable & non-viable particulate testing of facilities & utilities, viable (surface) monitoring of manufacturing facilities, personnel & biological hoods, moisture & oil content testing of compressed gases
  • Analytical/Microbiological Method Validation testing such as Bacteriosis & Fungistasis, linearity, specificity & robustness tests in protein chemistry, microbiology or complendial test methods
  • Assay trouble shooting experience in their expert area
  • Pharmacoepeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color & appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
Education:
  • Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years experience OR
  • MS degree in Science with 1 plus years experience
Description:
  • To provide expertise to their designated QC group & to accurately assess the purity, potency, efficacy & other performance characteristics for the purpose of supporting both manufacturing & quality assurance in the production, release & monitoring of established product lines
  • Coordinate & perform assays for their designated laboratory
  • Routine in-process, final product (antigens) protein chemistry testing for release of product
  • Routine in-process, final product (antigens) microbiological testing for release of product
  • Routine testing for release of Raw Materials
  • Routine testing for release of Seed Stock
  • Antigen Stability, reference/reagent qualification testing
  • Seedstock Stability testing
  • Cleaning & or Process Validation testing
  • Analytical Method Validation testing
  • Product/Method development testing
  • Use experience & method expertise to conduct troubleshooting
  • May be assigned to assist with OOS Investigations,
  • May be assigned to work independently on Validation, & Technical studies
  • May be assigned to assist with the planning & execution of OE projects
  • May be assigned to train staff on test methods
  • Comply Site Environmental Health & Safety (EH&S) requirements
 *Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 
 
 

 

Job Requirements

 
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Job Snapshot

Location US-CA-Oakland
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Other, Clinical & Scientific

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Terms & Conditions
Snapshot
Ascent
Company:
US-CA-Oakland
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Other, Clinical & Scientific
Store Type:

Job Description

19-04737 / Senior QC Analyst
Location: Emeryville, CA (Local candidates Only!)
Industry: Biotechnology / Pharma
Type: Quality Control: Testing
Level: 3 years of professional GMP testing experience.
 
Bay Area residents, who submit a cover letter prioritized!
 
Summary of job:
Use experience in all analytical assay method training to coordinate & perform critical material qualification & maintenance and/or other projects that are in addition to typical release, reference/reagent qualification and/or stability testing.

Must Haves:
  • At least 1-3 years' experience in a regulated GMP testing laboratory
  • Proficient in MS Word, MS PowerPoint & MS Excel software
  • Must be familiar with GMP's & Quality System Regulations (QS Regs)
  • Must have good time management, effectively prioritizing tasks for completio
  • Must have substantial (3 or more) assay testing experience in one of the main areas listed below:
  • Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's & in vitro diagnostic test kits.
  • Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing & Growth Promotion.
  • Bacterial & Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity & phenotype testing, DNA Plasmid isolation & restriction digest testing.
  • Environmental/Utility/facility Monitoring testing such as Sampling of & testing of manufacturing water by membrane filtration, viable & non-viable particulate testing of facilities & utilities, viable (surface) monitoring of manufacturing facilities, personnel & biological hoods, moisture & oil content testing of compressed gases
  • Analytical/Microbiological Method Validation testing such as Bacteriosis & Fungistasis, linearity, specificity & robustness tests in protein chemistry, microbiology or complendial test methods
  • Assay trouble shooting experience in their expert area
  • Pharmacoepeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color & appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
Education:
  • Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 3 years experience OR
  • MS degree in Science with 1 plus years experience
Description:
  • To provide expertise to their designated QC group & to accurately assess the purity, potency, efficacy & other performance characteristics for the purpose of supporting both manufacturing & quality assurance in the production, release & monitoring of established product lines
  • Coordinate & perform assays for their designated laboratory
  • Routine in-process, final product (antigens) protein chemistry testing for release of product
  • Routine in-process, final product (antigens) microbiological testing for release of product
  • Routine testing for release of Raw Materials
  • Routine testing for release of Seed Stock
  • Antigen Stability, reference/reagent qualification testing
  • Seedstock Stability testing
  • Cleaning & or Process Validation testing
  • Analytical Method Validation testing
  • Product/Method development testing
  • Use experience & method expertise to conduct troubleshooting
  • May be assigned to assist with OOS Investigations,
  • May be assigned to work independently on Validation, & Technical studies
  • May be assigned to assist with the planning & execution of OE projects
  • May be assigned to train staff on test methods
  • Comply Site Environmental Health & Safety (EH&S) requirements
 *Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role* 
 
 

 

Job Requirements

 
Senior QC Analyst Apply now