QA Compliance Specialist I
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Role Summary
QA Compliance Specialist I performs compliance activities in support of production and engineering to ensure all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. Provides floor support to production departments, including line clearances, in-process checks and investigations. Participates in quarterly audits and internal, customer, and regulatory audits as part of the Audit Team.
Responsibilities
- Review and approve supplemental logs, charts and other documents in support of cGMP operations
- Review batch records for accuracy and completion prior to final release of product
- Perform product releases for fills and intermediates lots
- Coordinate product releases with distributors and customers as needed
- Review and approve incoming materials for release
- Provide quality assurance support for investigations including nonconformance and root cause analysis
- Perform quarterly walkthrough audits of manufacturing and packaging; complete audit activities as assigned
- Issue, review and reconcile batch records as needed
- Assist in the maintenance of the Quality System
- Participate in project teams and perform other related duties as assigned
Qualifications
- Bachelor’s Degree or equivalent experience
- Medical device quality system management experience or an acceptable combination of education and experience; internship experience may be considered
- Knowledge of GMP, FDA, ISO requirements
- Computer competence including experience with database and Microsoft Office
- Excellent written and verbal communication skills
Skills
- Experience in GMP/ISO environments
- Good presentation and organizational skills
- Attention to detail
- Ability to execute tasks per defined policies and procedures to resolve routine issues
Education
- Bachelor’s Degree or equivalent experience