QA Specialist

Company: Frontage Lab
Location: Deerfield Beach
Posted on: November 22, 2021

Job Description:

Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug discovery and development. Frontage is a great place to work because it truly values its employees and their contribution to the organization. At Frontage great work is recognized and rewarded! Deerfield Beach (formerly Ocean Ridge Biosciences) is the newest location for Frontage and is focusing on providing genomics services including whole genome sequencing, metagenomics, polymorphism analysis, and gene expression profiling for applications in drug discovery, pharmacokinetics / pharmacodynamics (PK/ PD), companion diagnostics development, and others. The Deerfield Beach lab is currently seeking a Quality Assurance (QA) Specialist to lead a new Quality Assurance (QA) team in Florida. This is a great opportunity to establish and grow your career in QA because genomics, sequencing, and PCR-based assays is still an evolving area with respect to FDA regulatory guidance; this opportunity allows you to become a leader in this new area. Description: The QA Specialist will implement, maintain and enhance quality procedures and systems at the Deerfield Beach laboratory to ensure compliance with US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidance and publications. The selected individual will report to and work with the QA Manager for the Bioanalytical business unit at Frontage and will manage the transfer and implementation of company-wide policies, procedures, and standard operating procedures (SOPs) to the Deerfield Beach site. He/she will maintain and safeguard compliance-related documents such as SOPs, employee training records, audit reports, and detailed notes. The selected individual will ensure that the laboratory practices remain compliant with ever-changing government guideline and industry standards. In particular, since the Deerfield Beach location will focus on genomics assays where federal guidelines are not always well defined, the QA Specialist will provide recommendations to managers and study directors regarding best practices for conducting genomics assays following industry consensus, informal FDA guidelines, and guidance for related non-genomics laboratory assays. The QA Specialist will provide quality training to staff and will keep track of and report quality issues to supervisors, study directors, and management, as appropriate. He/ she will conduct quality audits internally as well as for current and potential vendors of Frontage. The QA Specialist will host external regulators and clients during audits of the Deerfield Beach facility. Requirements: The position requires a B.S. or M.S. degree in a scientific discipline that is relevant to pharmaceutical drug discovery and genomics and three or more years of full-time work experience in an academic or commercial laboratory focused on genomics, molecular biology, cell and gene therapy, immunology, or related discipline. An additional 3 years of work experience in the area of quality assurance, particularly as related to maintaining compliance with GLP or GCLP guidelines and FDA guidance related to NGS or bioanalytical assay development is highly desirable but not required. A working knowledge of GLP, GCLP, and Bioanalytical assay validation is essential. The selected individual will possess excellent communication skills including proficiency in workplace presentations, technical writing and editing, grammar and spelling, and note taking and transcription. A fervent desire to establish or grow in a career track in Quality Assurance as it applies to the Drug Discovery industry is essential. Application Procedure: Please submit a cover letter describing your reasons for applying to Frontage along with a resume that highlights your experiences and skills that are relevant to the position. Compensation: TBD depending on credentials, background, and level of expertise in subjects making up the job description. Position includes health, dental, vision, and 401K plan. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Keywords: Frontage Lab, Deerfield Beach , QA Specialist, Other , Deerfield Beach, Florida