Quality Control Analyst III
A global bio-pharmaceutical corporation is seeking to hire a QC Analyst III for a 12-month contract for their Vaccine Business Unit & Quality Technical Operations organization. The position will work closely with internal stakeholders including Quality Assurance, Analytical Development, CMC, and Regulatory Affairs as well as with contract testing laboratories.
The Quality Control Analyst III will be responsible for: 1) serving as a SME for analytical methods, microbiological methods, and stability for vaccine programs. 2) Analyze stability data and assess for trends. 3) Review, enter, verify, and analyze data for GMP release and stability testing of drug substances and drug product materials. 4) Review and author GMP documents such as microbial control plans, stability reports, method validation protocols and reports, and other documents for communication with regulatory agencies. 5) Technical assessment of methods for compliance to GMP requirements, guidance documents, and analyses of critical quality attributes. 6) Support supplier audits, review quality agreements, review CoA, and assist with batch disposition.
Location: Cambridge, Massachusetts
Duration: 12-month contract
Compensation: $60-65 per hour
Requirements & Skills
- Education: Bachelors of Science degree or Masters of Science degree with 4-6 years of industry experience.
- Knowledge of cGMPs (US and EU) and CMC regulatory requirements, and strong technical expertise in microbiology and microbial methods, and statistical methods for data analyses.
- Stability and microbiological experience is highly desirable.
- Working knowledge of statistical software programs such as JMP is highly desirable.
- Knowledge and skills in chemistry and biochemistry, and/or microbiology
- Good time and project management skills, ability to oversee several projects simultaneously.
Sthree US is acting as an Employment Business in relation to this vacancy.