Address
Form of work
SalaryJob Family / Sub-family
Quality & Regulatory - Quality Assurance
Contract type
Permanent
Job title
Quality Assurance SpecialistM/F/D
Position Context:
Perform review and release of Active Pharmaceutical Ingredients (APIs) in support of early Phase clinical product manufacturing. Assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities. Interacts with personnel from all departments of Seqens to ensure and maintain a high level of GMP compliance linked to the Group Quality requirements.
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
USA, Massachusetts, Devens
