Quality Assurance Specialist
2 hours ago
The Quality Specialist will play a crucial role in supporting manufacturing operations by becoming familiar with site processes, procedures, and policies. This individual will develop knowledge aligned with cGMPs and Health Authority regulations, ensuring compliance and quality standards are met.
Key Responsibilities:- Support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality-related documentation.
- Assist in auditing classified (Grades A/B/C) areas, including getting certified for Grade A/B gowning.
- Perform quarantine functions and accountability reviews.
- Support special projects as assigned.
- Follow cGMP and make decisions using cGMP/process knowledge.
- Work with customers to resolve problems and satisfy quality and production needs.
- Follow site safety requirements.
- Author, review, and approve data/documents such as methods, procedures, and/or protocols.
- Perform all work and complete assignments in a timely manner.
- Track/report metrics as needed.
- Provide training/presentations as needed.
- Assist with regulatory inspections.
- Bachelor's Degree in Science, Health Science, Engineering, or related discipline.
- 1-3 years of industry experience.
- Previous experience in the pharmaceutical industry.
- Preferred experience in Quality Assurance/Engineering role or Technical role.
- Lean Six Sigma Certification.
- Previous experience with SAP, MEDS, etc.
- Beta Lactam screening required for this role.
- Shift Requirements: 8am-5pm.
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