Quality Systems Specialist

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.

#LI-SB4