Proclinical is currently recruiting for a Quality Assurance Investigator with a pharmaceutical and biotechnology company located in Burlington, MA. The Quality Investigations Specialist will work within the Quality Assurance team in collaboration with other departments to conduct deviation investigations, root cause analysis, and support corrective actions. This individual will assist with ensuring compliance with cGMPs, company, customer and regulatory quality standards according to requirements. Specifically, this individual will be responsible for writing, reviewing, and/or approving investigations to ensure compliance with established standards. The quality systems investigations include but are not limited to, deviations, customer complaints, COTs, EM-viable, EM non-viable and OOS.
Job Responsibilities:
- Work within the Quality Assurance team in collaboration with other departments to conduct deviation investigations, root cause analysis, and support corrective actions
- Assist with ensuring compliance of cGMPs and regulatory quality standards.
- Write, review and approve investigations to ensure compliance with established standards
- Investigations include deviations, customer complaints, COTs, EM-viable, EM non-viable and OOS
- Participate in the deviation, change control, complaint handling, and CAPA systems
- Ensure the processes and procedures meet current regulatory and industry expectations
- Lead investigation teams to ensure events are documented and appropriate CAPAs are identified
- Compile, track, analyze and report key performance indicators and metrics to identify areas of non-compliance, best practice and improvement
- Prepare information relating to QMS to be used in routine monthly reporting and meetings
- Proactively recommend to management areas of improvement within the various operations
- Stay current with regulatory expectations and industry best practices in quality systems investigations
- Safety awareness and safe work practices
Skills and Requirements:
- Bachelor's Degree in related field required, advanced degree preferred.
- 2+ years of experience in a QA or regulatory experience in the Pharmaceutical industry
- Understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing
- Able to organize complex technical document and to write clear, concise, complex reports, assessments and documents
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Amanda Rivera at 267-435-8555 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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