CareersQuality Assurance Associate

bt_bb_section_bottom_section_coverage_image
https://www.cosmosid.com/wp-content/uploads/2021/04/MICROBE_5.webp

Quality Assurance Associate

An individual in this role verifies compliance to applicable Standard Operating Procedures (SOPs) and regulations (GCP and/or GLP) by performing study protocol, data, report, in-lab phase inspections where applicable, for all study types within a laboratory. A QA Associate will lead in QA archive maintenance and record keeping, participate in internal and external facility and supplemental inspections, lead process improvement and harmonization efforts that promote best practices, initiate and review SOPs and prepare and deliver training in basic quality/regulatory matters. At this level the individual will be starting to gain experience in assisting with client inspection hosting, and general QMS auditing.

Responsibilities:

  • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
  • Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records)
  • Performs study sign-off including but not limited to QA statement preparation/review (internal/external) and report finalization
  • Participates in internal and external facility and supplemental inspections
  • Performs protocol, data, report, and in-lab phase inspections for all study types within a single laboratory to verify conformance to applicable SOP and regulatory requirements
  • Prepares and delivers basic quality/regulatory training
  • Manage all Clinical employee personnel files
  • Assist in the development of training and competency of all clinical employees.
  • Leads process improvement and harmonization efforts that promote best practices
  • Coordinates the efforts for maintaining an effective quality system
  • Manages, maintains and improves the QA system to meet the regulatory standards
  • Oversees the review, update and maintenance of all SOP’s and other QA documents
  • Performs regular facility audits to ensure compliance to our quality system, pertinent regulations, and governing regulatory body requirements
  • Communicates any critical compliance risks to senior management
  • Assist in the development, notification and implementation of Quality Control Systems.
  • Assisting with the preparation, coordination, and management of regulatory agency inspections
  • Lead/support investigator site, vendor, and internal process audits per procedures and applicable regulatory requirements
  • Support the implementation of the Vendor Oversight Program for Development non-clinical and clinical programs/studies with the focus on quality and compliance perspectives
  • Monitor Vendor Quality Agreements and update Approved Vendor Lists
  • Assist in preparation and/or management of regulatory agency inspections and in enhancing inspection readiness program
  • Assist in the review and/or approval of GLP/GCP and systems related SOPs to assess their adherence to applicable regulatory standards
  • Maintains working knowledge of FDA, EU and other global regulations and guidance governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Privacy Requirements
  • Executes other duties as delegated

Education, Experience, other Requirements and Qualifications:

  • BA/BS, preferably in a scientific discipline or life sciences. (Required)
  • Experience as a quality auditor in a GxP-regulated environment or experience in a GLP regulated CRO (Preferred)
  • 2+ years experience
  • Molecular Biology experience (Preferred)
  • Knowledge of a High Complexity clinical testing environment (Preferred)
  • Possess the technical and administrative abilities required to carry out routine audits with minimal supervision and to play a supporting role in more complex audits
  • Strong knowledge of Good Clinical Practice/ICH guidelines; CLIA/CAP regulatory requirements, LDT product/assay development process and clinical monitoring procedures
  • Experience in auditing and implementing FDA CFR and EU ICH regulatory requirements and other global ICH harmonization regulations
  • Experience writing SOPs which support GLP/GCP/CLIA activities
  • Good knowledge of Computer System Validation related to predicate rules
  • Project Management experience and skills a plus
  • Strong interpersonal skills, team player, and flexible without compromising quality
  • Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
  • Ability to work efficiently and independently
  • Excellent oral and written skills across many audience levels
  • Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint)
  • Ability to embrace new technologies

Position Type: Full-Time

Compensation is market competitive, and based on the experience and the expertise of the selected candidates. The candidate should have a legal work permit to work in the US. Interested candidates are invited to send their CV and cover letter to jobs@cosmosid.com