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QA Specialist

Frontage Laboratories Deerfield Beach, FL

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Frontage Laboratories:

Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. 

Deerfield Beach:

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, PK/PD, companion diagnostics development, and others. The Deerfield Beach lab is looking for a Senior Research Scientist with substantial expertise in Molecular Biology, Genomics, and Assay Development.

Position Summary:

The Deerfield Beach lab is currently seeking a Quality Assurance Specialist to lead a new Quality Assurance (QA) team in Florida.The QA Specialist will implement, maintain and enhance quality procedures and systems 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.

Responsibilities:

Responsibilities will include but will not be limited to:

  • Conduct QA audits of BIO laboratories and functions including but not limited to ongoing process, data review audits, technical report, and study independent facility / process.
  • Provide input to method, equipment, and computer validation programs.
  • Assist with oversight of Master Schedule.
  • Maintain appropriately detailed notes, audit reports, and records
  • Provide input to documentation and data storage systems.  
  • Ensure that requirements and documentation for all regulated systems are kept current according to changing guidelines and industry standards. 
  • Provide Regulatory training to staff as necessary. 
  • Effectively report quality issues to supervisor, Study Director, and management, as appropriate.
  • Provide oversight and input to investigations and CAPA, as appropriate
  • Conduct outside vendor audits as may be required, including laboratories and services for subcontracting and/or supporting services, and follow-through on any quality issues. 
  • Review and maintain Standard Operating Procedures (SOP).
  • Assist with client audits and regulatory inspections.

Requirements: 

The selected candidate will possess a B. S. degree in a scientific discipline that is relevant to pharmaceutical drug discovery and genomics; for example, biological sciences, organic chemistry, physical chemistry, biotechnology, biomedical engineering, computer science or quality systems would be appropriate degree areas. The position requires 3 or more years of experiencing in quality assurance related to maintaining compliance with GLP or GCLP, or the same amount of experience working in a laboratory governed by GLP / GCLP rules with substantial experience in quality control and interacting with the QA department. 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. Preference will be given to candidates with experience within labs operating in the areas of molecular diagnostics, genomics, or bioanalytical assays.

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.  


Frontage Laboratories

Address

Deerfield Beach, FL
33442 USA

Industry

Technology

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