QA Specialist - Equipment and Computer Systems
Location
Cambridge, MA | United States
Job description
QA Specialist - Contract - Onsite
Proclinical is seeking a QA Specialist - Equipment and Computer Systems to join a global biopharmaceutical company. This is a contract role located in Cambridge, MA.
Skills & Requirements:
- Specialization in Vaccines - Life science - Bioinformatics - Computer Engineering - Regulatory Requirements in Pharmaceutical environment
- Minimum Level of Education - University Degree in Science (Chemistry, Biology, biochemistry, Bioengineer or Pharmacy)
- At least 5 years' experience in validation methodologies and related documentation (V Cycle, GAMP 5, Agile). Good knowledge of international standards, GXP expectations. Good knowledge of inspection process.
- Knowledge of R&D environment is beneficial
- Knowledge in the following areas is beneficial:
- Software and hardware development.
- Project management and risk management principles and tools.
- Spreadsheets validation (Excel, SofMaxPro,…).
- Good communication skills are expected as well as a spirit of initiative.
- Strong presentation skills. Ability to prepare training content and deliver training session.
- Customer focused and flexible thinking
- Ability to manage networks and build relationships transversally across the Vaccines network.
- Ability to adapt, work under uncertainty and accommodate flexible work demands.
- Self-motivated; Sense of urgency.
- Knowledge and expertise of quality systems in a pharmaceutical environment, such as, Deviation, Documentation Management, Training, Change Control, CAPA
- Must be eligible to work in the US.
The QA Specialist will:
- Approve documents created as part of the validation/ qualification of computerized systems and equipment (e.g. reports/protocols)
- Contribute to the development/improvement of computer validation and equipment management methodology as part of the site integration into our standards
- Oversee that the R&D data generated electronically (or hybrid process) is obtained, used, back-ups performed and archived in accordance with Data Integrity principles, GxP, corporate and international regulations
- Support internal and external audits and contribute to inspection readiness upon request
- Support management of deviations and risks to evaluate potential impacts on quality and determine mitigation actions
- Provide QA expertise and support to relevant stakeholders
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or [email protected] .
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.
INDCQA
Job tags
Salary