- Review and approve supplemental logs, charts and other documents in support of cGMP operations.
- Review batch records and certificates of analysis for accuracy and completion prior to final release of product.
- Maintain the Approved Supplier List including updating and reviewing performance of vendors.
- Provide quality assurance support of investigations including: nonconformance, CAPA, root cause analysis, complaints, out of specification and environmental excursions.
- Provide quality input and maintain the files for change controls and planned deviations.
- Provide document control support.
- Issue and reconcile batch records.
- Maintain device history files.
- Perform internal and external audits as assigned.
- Assist in the maintenance and implementation of the Quality System.
- Perform Material Master data transactions in the ERP system, specifically SAP.
- Participate in project teams and perform other related duties as assigned.
- Responsible for other duties and projects as assigned.
- Bachelor’s Degree required, preferably in the life sciences or relevant experience.
- 5+ years industry experience in a QA function.
- Knowledge of GMP/ISO requirements, specifically ISO 13485 Medical Devices.
- Experience auditing in a GMP/ISO environment.
Desired Experience, Knowledge, and Skills:
- Ability to interact positively and professionally with internal and external customers.
- Ability to work autonomously, effectively manage time and deliver results on time.
- Ability to perform Materials Master Data transactions in SAP.
- Requires proficiency in word processing, spreadsheets, and databases.
- Excellent presentation skills, both written and in platform presentation format.