Quality Analyst II
Quality Analyst II
Posted on :
12-03-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2617495
Job Title :Quality Analyst II
Pay Rate: $40.00/Hour on c2c (no other benefits)
Position Type: Contract 1 year with extension
Location: Exton PA United States
Description:
QC Analyst 2 will contribute to the success of the operation by providing accurate GxPcompliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies. Biopharmaceutical manufacturing runs typically cost in excess of 1$ million each and reach many times that for larger phase 3 campaigns while stability studies cost several hundred thousand dollars each and this individual has an important role in ensuring that release and stability testing generates accurate results without delays or compliance issues. The individual will help maintain the biochemistry laboratory systems assist in training other analysts help maintain SOPs and other documents and promote an orderly and efficient laboratory workplace.
Education: BS in biological or chemical sciences or equivalent
Experience:
Minimum of 24 yrs working experience in a cGMP Quality Control analytical development analytical transfer or validation department in a FDAregulated industry.
Knowledge of principles concepts and practices in QC testing of protein biopharmaceuticals.
Handson experience with at least two techniques such as HPLC capillary electrophoresis ELISA or SDSPAGE used for analysis of recombinant proteins.
Knowledge of GxP requirements and ICH/FDA/EMA guidelines.
Ability to identify and help investigate assay and equipment problems.
Fluent in English good written communication skills; good interpersonal skills.
Team player who can excel in a handson entrepreneurial environment.
Physical requirements: handling of laboratory equipment chemicals and biological materials.
Remarks:
We are looking for someone with a few years of analytical lab experience with pharm manufacturing inprocess release and stability testing that utilizes techniques such as HPLC ELISA Appearance capillary gel electrophoresis. PCR experience is a plus.
Pay Rate: $40.00/Hour on c2c (no other benefits)
Position Type: Contract 1 year with extension
Location: Exton PA United States
Description:
QC Analyst 2 will contribute to the success of the operation by providing accurate GxPcompliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies. Biopharmaceutical manufacturing runs typically cost in excess of 1$ million each and reach many times that for larger phase 3 campaigns while stability studies cost several hundred thousand dollars each and this individual has an important role in ensuring that release and stability testing generates accurate results without delays or compliance issues. The individual will help maintain the biochemistry laboratory systems assist in training other analysts help maintain SOPs and other documents and promote an orderly and efficient laboratory workplace.
Education: BS in biological or chemical sciences or equivalent
Experience:
Minimum of 24 yrs working experience in a cGMP Quality Control analytical development analytical transfer or validation department in a FDAregulated industry.
Knowledge of principles concepts and practices in QC testing of protein biopharmaceuticals.
Handson experience with at least two techniques such as HPLC capillary electrophoresis ELISA or SDSPAGE used for analysis of recombinant proteins.
Knowledge of GxP requirements and ICH/FDA/EMA guidelines.
Ability to identify and help investigate assay and equipment problems.
Fluent in English good written communication skills; good interpersonal skills.
Team player who can excel in a handson entrepreneurial environment.
Physical requirements: handling of laboratory equipment chemicals and biological materials.
Remarks:
We are looking for someone with a few years of analytical lab experience with pharm manufacturing inprocess release and stability testing that utilizes techniques such as HPLC ELISA Appearance capillary gel electrophoresis. PCR experience is a plus.
Employment Type
Full Time
Key Skills
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