Pharmaceutical Quality Assurance Associate

3 weeks ago

Elkridge, United States Vici Health Sciences Full time

Essential Skills Needed:

- Quality orientation and high attention to detail.
- Excellent interpersonal and communication skills.
- Experience working with high performance teams.
- Problem analysis and problem resolution skills.
- Strong willingness to learn

Essential Duties & Responsibilities:

- Major responsibilities include reviewing GMP documentation, status control of Raw Materials and Finish Product, participate in internal audits; keeping the information well organized and in a state of inspection readiness; maintaining record integrity and security; initiating, reviewing, and revising Standard Operating Procedures; ensuring compliance to FDA and DEA; interpreting federal and local regulations and providing regulatory support
- Maintain the QA compliance systems in accordance with U.S. Regulations and internal standards
- Maintain the Quality Assurance compliance systems in accordance with U.S. Regulations and internal standards
- Perform review of documents related to GMP activities; may act as liaison for commercial project with vendor.
- Ensure that all inspection and equipment to meet the specified calibrations.
- Maintain and track the status of Vici formulation and analytical equipment using Equipment Master Lists and equipment change controls (ECRs).
- When appropriate, assist in all FDA inspections regarding Vici regulated activities
- When appropriate, assist in internal audit procedures at Vici
- Assemble and prepare meeting requests and packages as part of direct correspondences with the FDA.
- Track and manage the completion of deviation investigations and related corrective actions/preventative actions (CAPA).
- Initiate and revise SOPs as needed.
- Maintain and track document change record (DCRs)
- Ensure the training of all employees and maintain training records.
- Maintain and distribute documents to appropriate departments.
- Conduct inventory tracking and analysis for inventory and ARCOS.
- Serve as a regulatory representative in project teams, and provide regulatory support for new products.
- Write controlled correspondences as part of direct correspondence with the FDA regarding product development and formulation.
- Identify relevant guidance documents and provide interpretive assistance
- Review protocols and applied studies to ensure collection of data needed for regulatory submissions
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Compile and maintain regulatory documentation

Pay: $40,000.00 - $65,000.00 per year

**Benefits**:

- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Schedule:

- Monday to Friday

Work Location: In person

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