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Job #03102

About our client Our client is a growing CRO headquartered in Massachusetts that specializes in providing pre-clinical laboratory services for leading medical device, biotech and pharmaceutical companies. They have an experienced management team, a learning and team focused culture and a strong reputation with their customers. This is a great opportunity for the right candidate. Position Location Quality Assurance Manager Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare GLP and non-GLP (non-routine) reports 2) Review all data, protocols and reports for compliance and accuracy 3) Act as support for the Quality Assurance unit 4) Monitor all GLP and non-GLP study schedules and ensure timely tracking of related data phase and report audits and item closeouts 5) Ensure that the protocol assigned to a study is current 6) File copy protocols, requisition updates when necessary and maintain ongoing active reviewing of procedures 7) Develop and update assigned SOPs 8) Audit SOPs’ implementation and compliance 9) Assist in monitoring annual reviews 10) Update and develop toxicology SOPs, quality system audits, compilation of ISO data for management reviewing 11) Conduct phase, raw data and report audits 12) Participate in regulatory and sponsor audits (as required) 13) Assist with internal audits (ISO/GLP) and related reporting 14) Interact with sponsors on quality issues related to toxicology and P. Chem. studies 15) Review all new data or procedural documentation formats 16) Conduct reviews of all related views for non-GLP and GLP studies including phase audits (auditing of computer systems vs. printed material) 17) Review and assist (as required) in log-in and archiving activity audits 18) Ensure accuracy of equipment SOP distribution lists 19) Review of records (monthly) and historical file maintenance 20) Interface with Technical, Sales and Marketing and Administrative Departments related to quality assurance issues 21) Ensure availability and use of preventative maintenance logs 22) Assist in updating ISO 9000 quality systems program 23) Submit status reports related to system and performance audits of the laboratory to management and study directors 24) Maintain conformance to quality mission statement, goals and values 25) Enforce and maintain compliance with ISO 9001 certification through laboratories and Operations 26) Oversee quality assurance planning as well as activities and programs for special projects including validation activities at all levels 27) Organize and set up quality activities related to MIS including process control and planning activities for automation and hardware/software computer validation 28) Assist the management in special projects and quality management 29) Review and oversee Quality Assurance staff Requirements 1) Bachelor’s degree in Biology 2) In-depth experience in GLP and FDA audits 3) Knowledge of technical/regulatory procedures and GLP regulations 4) Excellent editing, writing and proof-reading skills 5) Good computer skills 6) Superb organizational skills 7) Ability to prioritize and meet deadlines with a high volume of reports 8) Ability to work on several projects concurrently in a fast-paced environment 9) Self-starter and teamwork-oriented