Summary:
EM2 Solutions is your complete source for quality, regulatory, and staffing support. EM2 provides customized support solutions to fit your immediate and long term needs. We can assist with short or long term projects or provide you the personnel to fill your temporary, temporary to direct and direct hire needs. Our expertise lies in the technical and scientific fields. Whether you are looking for a new career opportunity or personnel for your own organization, EM2 is ready to work for you.
Full Description:
EM2 can act as an independent quality assurance unit or provide support to an existing quality management system. EM2 can seamlessly facilitate your transition to a new quality system standard or help you develop a customized solution for your business. We support:
• ISO 9001, ISO 17025 and ISO 13485
• Environmental (NELAC)
• GMP, GLP, IPEC:PQG
Examples of QA services offered by EM2 include:
• Gap Assessments
• Audits (Internal & External)
• Standard Operating Procedures
• Training
• Document & Form Management
• Root Cause & CAPA
• Customer Complaint Investigations
• Statistical Process Control
• Vendor Qualifications
Regulatory Services
EM2 specializes in laboratory, manufacturing, and distribution operations in the pharmaceutical, dietary supplement, medical device and excipient industries. We are able to provide expert consultation on quality system regulations or complete submissions of regulatory documents. Our services include:
• Equipment Qualification (process & analytical)
• Validation Protocols (process & software)
• Medical Device Regulatory Submissions
• Drug Master Files
Database Services
EM2 consultants are experts in laboratory and quality assurance software projects. We have successfully implemented systems from $20K to $1M+. We provide software implementation project management, configuration and can even provide routine system administration. If you are looking for a new system, EM2 can ease the decision making process by clearly defining system and user requirements and then help select the appropriate vendor based on your company's needs.
• Laboratory Information Management Systems (LIMS)
• Electronic Document Management Systems (EDMS)
• Quality Assurance Tracking Software
• Laboratory Instrument Software
Staffing Solutions
Whether you are looking for a new career opportunity or personnel for your own organization, EM2 professional recruiters are ready to work for you. We specialize in placing people in scientific and technical positions. We recognize the cost associated with hiring professionals and want to help clients find the right person for each job order we receive.
• Quality Assurance
• Chemists & Lab Techs
• Engineers & Operators
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