1 Quality Assurance Specialist M/F/D Job in Devens, MA
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seqens is Hiring a Quality Assurance Specialist M/F/D Near Devens, MA
Job Family / Sub-family
Contract type
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Position Context:
Main tasks :
- Reviews batch records, documents, validation protocols, and reports for compliance to internal and GMP standards.
- Reviews QC analytical data from in-process, release and stability testing.
- Supports the department during client audits and FDA inspections, if needed.
- Provides Quality Assurance on-the-floor oversight to production and quality
- Work directly with production, project management, and quality control to ensure that deliverables meet quality requirements
- Carries out any other duties which are within the employee’s skills and abilities whenever reasonably instructed
- Assists in the scheduling and maintenance of Quality Assurance activities and systems.
Required skills :
- BS in a scientific discipline or equivalent with a minimum of 0-3 years’ experience in an GMP regulated industry.
- Associates degree in a scientific discipline or equivalent work experience with a minimum of 2-5 years of experience in a pharmaceutical, or quality field.
- High School Diploma or equivalent with a minimum of 5 years of experience in a pharmaceutical, medical, or quality field.
- Knowledge of Quality Assurance oversight and support for all phases of clinical trials.
- Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations
- Knowledge of and previous experience with GMP, ICH Q7, and 21 CFR Part 11 preferred
- Familiar within FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals preferred
- Experience with clinical phase pharmaceuticals preferred.
Position location
Job location
Job Summary
Full Time
$101k-122k (estimate)
03/07/2024
05/06/2024
seqens.com
ECULLY, AUVERGNE-RHONE-ALPES
500 - 1,000
2003
PIERRE LUZEAU
$10M - $50M
Related Companies
The job skills required for Quality Assurance Specialist M/F/D include Quality Assurance, Quality Control, Project Management, Scheduling, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Specialist M/F/D. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Specialist M/F/D. Select any job title you are interested in and start to search job requirements.
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