Quality Assurance Specialist

2 days ago


Manassas, Virginia, United States Granules Full time
Job Description

At Granules, we are seeking a highly skilled Quality Assurance Specialist to join our team. This role is responsible for ensuring compliance with cGMP and internal policies, procedures, and specifications.

The ideal candidate will have a strong understanding of cGMP requirements, FDA regulations, and ICH guidelines. Key responsibilities include:

  • Managing and maintaining company document control and archival systems.
  • Routing, reviewing, approving, distributing, and archiving new and revised controlled documents.
  • Tracking controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports.
  • Archiving and maintaining hardcopy and electronic copies of batch records files, audit files, vendor files, product label files, and change history files.
  • Controlling and issuing labeling components.
  • Managing all document control logbooks and spreadsheets.
  • Performing the release of finished product batches packaged.
  • Providing new hire training on GMPs, Safety, and Pharmacovigilance and maintaining the training program documentation.
  • Ensuring standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.
  • Collaborating with team members to ensure timely deliverables for documentation.
  • Ensuring all documents are up to date with respect to version control and issuance.
  • Performing and supporting maintenance and closure activities of documents such as reports, protocols exceptions/deviations, CAPAs, change controls, and complaints.

Requirements:

  • cGMP compliance within the pharmaceutical manufacturing industry.
  • Writing and maintaining cGMP documentation.
  • Analyzing data/information and resolving complex issues.
  • Verbal and written communication skills.
  • Working and communicating with cross-functional teams.
  • Multiple priorities and re-prioritizing tasks.

Experience & Education:

  • At least two (2) years' experience in a quality assurance role in a cGMP-regulated environment.
  • A college Degree preferably in Sciences (i.e. Pharmacy, Biology, Chemistry etc.).

Physical Requirements/Working Environment:

  • While performing the duties of this job, the employee is regularly required to stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.
  • Specific vision abilities required by this job include close vision requirements due to computer work.
  • Ability to sit at a computer terminal for an extended period of time.
  • Light to moderate lifting up to 10-15 lbs. is required.
  • Ability to work in a confined area.


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