Mosaic Laboratories, a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies, has an opening for a Quality Assurance Auditor. The Quality Assurance Auditor will:
Contribute to the operation of the laboratory in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on GLPs, GCPs, CLIA, and College of American Pathologists (CAP) accreditation and inspection criteria, and applicable company policies, procedures and quality initiatives.
Review testing, quality control, and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality assurance standards and regulatory requirements are met.
Review study reports for accuracy, omissions, compliance with work statement, compliance with appropriate regulations and guidelines, formatting, spelling and grammatical errors, and other items to ensure the highest quality final report.
Perform and document internal study audits at defined intervals and report results to Study Director and Management.
Participate in inspections of laboratory operations, document audit findings and report results to the Study Director and Management.
Host FDA, OSHA, CLIA, CAP, client, and other inspections as necessary.
Maintain SOPs, including proper revision notification and monitoring, proper copying and distribution, and proper implementation.
Write and update Quality Assurance SOPs as needed.
Maintain current and accurate records of all relevant communications, audits, and corrective action plans.
Provide prompt and professional communication with staff regarding Quality Assurance matters.
Maintain the master schedule.
Maintain critical company records including operational, training, facility and safety records.
Perform periodic laboratory monitors and report results to management.
Manage proficiency testing program.
Minimum of a Bachelors' degree with a preference for a B.S.. Must have experience in a clinical laboratory with compliance with CAP, CLIA and state laboratory regulations. Must have at least 2 years of experience performing quality assurance audits in a clinical, pharmaceutical or biotech environment. Ability to grasp verbal and written instructions in English quickly and to interface with people at all levels of the organization. Computer skills including word processing, spreadsheets and general data analysis. Attention to detail and the ability to perform 100% QC checks on large amounts of data. Organization, professionalism, accurate documentation skills in English and the ability to comply with regulatory requirements are essential. Excellent reliability to follow through and complete assignments. Preference for CLS with quality assurance accreditation, but not required.
Mosaic Laboratories is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law.
Mosaic Laboratories is a leading provider of pre-clinical and clinical trial laboratory services to pharmaceutical and biotechnology companies. Our mission is to provide unparalleled quality of analytical services, study design guidance, result interpretation and customer service in order to significantly impact the future of patient therapy. We are currently working with over 120 pharmaceutical ...and biotech companies, including clients in the United States, Europe and Asia. Our laboratory service offerings include IHC, FISH, ISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, ELISA, mutation testing, cell expansion, and colony forming assays. Mosaic Laboratories was the first laboratory to develop methods for accurate multiplex chromogenic immunohistochemistry using multispectral imaging, and is a leading provider of immuno-oncology testing services. We are a CLIA licensed and CAP accredited laboratory, and perform appropriate studies in compliance with the relevant portions of Good Laboratory Practices and Good Clinical Practices.