The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.
Mxf2ly6689r56wwlyjq

QC Analyst

Job Description

19-08739 / QC Analyst 
Industry
: Biotechnology / Pharma
Location: Emeryville, CA
Type: Initial 6-12month contract with opportunity to extend and or convert

Local candidates who submit a cover letter prioritized!

Description:
  • 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.
  • 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
Must Haves:
  • 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
  • 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 completion
 *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

 

Job Snapshot

Location US-CA-Emeryville
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Other
Apply

Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-Emeryville
Bonnie Galley
Icon-social-facebookIcon-social-linkedinIcon-social-twitter
Snapshot
Ascent
Company:
US-CA-Emeryville
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

19-08739 / QC Analyst 
Industry
: Biotechnology / Pharma
Location: Emeryville, CA
Type: Initial 6-12month contract with opportunity to extend and or convert

Local candidates who submit a cover letter prioritized!

Description:
  • 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.
  • 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
Must Haves:
  • 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
  • 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 completion
 *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

 
M0z7hj6l4qd6vywwmj7
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
QC Analyst Apply now