Quality Analyst - Exton, United States - Techmatrix inc
Description
Title:
Quality Analyst II
Position Type:
Contract 1 year with possibility of extension
Location:
Exton, PA, United States
Description:
QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant 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 SDS-PAGE, 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.
Job Types:
Full-time, Contract
Pay:
$ $25.00 per hour
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- Manufacturing: 1 year (preferred)
Shift availability:
- Day Shift (preferred)
Work Location:
On the road
More jobs from Techmatrix inc
-
Warehouse Worker/assembler
Austin, United States - 3 weeks ago
-
Maintenance Technician
Sparks, United States - 1 week ago
-
Mechanical Technician/manufacturing Technician
Brea, United States - 1 week ago
-
Production Operator
Malvern, United States - 1 week ago
-
Medical Assembler
Austin, United States - 2 days ago
-
Calibration Technician
San Diego, United States - 5 days ago