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Quality Assurance Documentation I

Bogart, GA 30622

Posted: 01/23/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 535273 Is job remote?: No Country: United States

Job Description

Position Summary
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.
Pay Range: 18-22/hr
Salary will be commensurate with experience
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