Quality Assurance Specialist
2 days ago
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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