QA Specialist - Equipment and Computer Systems job in Cambridge, USA

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

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