QA Specialist

Found in: beBee jobs US - 3 weeks ago

Cambridge, Massachusetts, United States Proclinical Full time

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 environmentMinimum 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 beneficialKnowledge 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 thinkingAbility 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, CAPAMust 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 standardsOversee 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 regulationsSupport internal and external audits and contribute to inspection readiness upon requestSupport management of deviations and risks to evaluate potential impacts on quality and determine mitigation actionsProvide 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 or

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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