Quality Systems Specialist job in Waltham, USA

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Last Name*

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First Name*

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Job type: Permanent

Discipline: Laboratory Technician

Location: United States

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

Proclinical is currently recruiting for a Quality Systems Specialist with a pharmaceutical company located in Waltham, MA.

Job Responsibilities:

Coordination and maintenance of Quality Management System (QMS) Gap analysis, interfacing with site SMEs for QMS Gap analysis completion, disseminating and evaluating recommended assessment levels for identified gaps.
Develop and/or revise, coordinate the implementation of standard operating procedures, guidances and/or instructions.

Skills and Requirements:

Sc. Degree or equivalent experience
Experience with technical writing, formatting skills (specifically, SOPs, working instructions, guidances, etc.) is a must.
Command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations.
Experience with documentation and knowledge management (electronic document management systems); training curricula implementation/revision; training delivery (writing quizzes, classroom training…).
Experience of working in teams to improve processes or resolve problems. Knowledge of data integrity requirements.
Experience with data review (analytical reports, batch records, investigations, development reports and raw data), working with CDMOs is a plus.

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

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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