QA Specialist - Equipment and Computer Systems

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 j.cerchio@proclinical.com.

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