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Quality Assurance Specialist

2 months ago

Manassas, Virginia, United States Granules Full time
Job Overview

The Quality Assurance Specialist for Warehouse Operations at Granules Consumer Health plays a crucial role in ensuring adherence to cGMP standards and internal protocols. This position is tasked with conducting quality assurance inspections for incoming materials, overseeing the release process, sampling, and reviewing shipments, as well as managing inventory control and quality system functions in line with cGMP and relevant company SOPs, as well as applicable laws.

Key Responsibilities:

  • Oversee quality assurance activities that support Warehouse Operations in alignment with Granules' policies and global cGMP standards.
  • Conduct inspections of bulk materials, packaging components, finished products, and raw materials.
  • Perform sampling of bulk and packaging components, as well as finished products and raw materials.
  • Ensure compliance with GMP warehouse procedures, providing real-time reviews of warehouse documentation and collaborating with Warehouse Operations to address any discrepancies.
  • Monitor data impacting material quality, including environmental and temperature tracking.
  • Maintain both hardcopy and electronic records of label files and change history.
  • Manage the issuance and control of printed packaging components.
  • Oversee the stability, retention, and rejection of materials.
  • Assist with document copying and scanning as required.
  • Foster relationships with Warehouse Operations, Supply Chain, and other departments to enhance collaboration and resolve issues.
  • Ensure compliance with GMPs, Good Documentation Practices, and relevant procedures for storage, documentation, and material handling.
  • Review standard operating procedures regularly for relevance and accuracy in accordance with company policies.
  • Collaborate with team members to ensure timely completion of documentation tasks.
  • Support the maintenance and closure of documents, including reports, protocols, CAPAs, change controls, and complaints.
  • Be adaptable with working hours, including weekends and off-hours, to meet operational needs.
  • Maintain cGMP compliance within the facility.
  • Perform any additional tasks as assigned by the Supervisor.

Qualifications:

  • Knowledge of cGMP compliance within the pharmaceutical manufacturing sector.
  • Experience in writing and maintaining cGMP documentation.
  • Adept at analyzing data and resolving complex issues.
  • Strong verbal and written communication skills.
  • Ability to work collaboratively with cross-functional teams.
  • Skilled in managing multiple priorities and re-prioritizing tasks as necessary.

Experience & Education:

  • A minimum of two years' experience in a quality assurance role within a cGMP-regulated environment.
  • A college degree, preferably in a scientific discipline (e.g., Pharmacy, Biology, Chemistry).

Physical Requirements:

  • Regularly required to stand, sit, talk, hear, and use hands for computer and telephone operations.
  • Specific vision abilities required include close vision for computer work.
  • Ability to sit at a computer for extended periods.
  • Light to moderate lifting of up to 10-15 lbs. may be required.
  • Ability to work in confined spaces.

This job description is intended to convey the general nature and level of work performed by employees in this role. It is not designed to be an exhaustive list of all duties, responsibilities, and qualifications required for this position.