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QA Specialist

Bogart, GA

Posted: 01/27/23 Category: IT Quality Assurance, Life Sciences Job Number: 19129

Job Description

Position: QA Specialist
Location: Bogart, GA
Job Type: Contract
Duration: 11 months

Job Description
  • The QA Specialist is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP in support of the manufacture, testing and release of product.
  • The QA Specialist works under normal supervision on routine work and receives detailed instruction and oversight on new assignments.
  • Performs all responsibilities in accordance with company policies, procedures, safety requirements and federal regulations.
Principal Responsibilities
  • Facilitates timely and accurate archiving of GMP documentation
  • Issues manufacturing harvest records, quality control assay worksheets, logbooks, etc.
  • Reviews manufacturing harvest records to certify compliance with specifications and procedures. 
  • Supports and completes required documentation for batch disposition.
  • Supports review of incoming materials for compliance to specifications, determines release status.
  • Inputting information from the Quality Systems into electronic databases and generating reports from these systems.
  • Capturing and reporting metrics around Quality Systems and Harvest Record review turn-around times and closure/approvals times.
  • Interacts professionally with company management, internal departments and other colleagues to effectively maintain Quality Systems.
  • Collaborate with teams to ensure efficient, compliant, and timely review and closure of GMP documents.
  • Participates in various project and technical meetings, as needed.
  • Minimum of 0-2 years GMP related experience in biopharmaceutical / pharmaceutical or related industry experience
  • Familiar with cGMPs and regulatory requirements
  • High School degree, BS/BA degree in Life Science or related field is preferred.
  • Learning and self-development, decision quality, collaborates, ensures accountability, cultivates innovation, resiliency
  • Excellent written and verbal communication skills
  • Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment
  • Ability to monitor and report on assigned tasks, goals and objectives
  • Collaborate with teams to ensure efficient, compliant, and timely review and closure of GMP documents.
  • Possess a strong attention to detail, planning, and organizational skills, with flexibility for changes in work priorities to plan and accomplish goals.
  • Use a team-oriented approach to problem resolution with an ability to work independently and collaboratively in a team structure.
  Queen Consulting Group is an equal opportunity employer. Our goal is to promote an environment that helps our employees and clients appreciate the benefits that diversity provides.

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Chelsea Calvanese
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