Quality Assurance Assistant

Vici Health Sciences is a growing pharmaceutical start up. This position will support Vici Health Science's Quality and Regulatory Assurance manager. This position is for a candidate focused and meticulous and has a desire for career growth. Must be able to effectively execute essential duties and responsibilities within a dynamic and shifting work environment.

Essential Skills Needed:

• Quality orientation and high attention to detail.
• Strong computer skills and high competency in applications such as MS Word, Excel, and Adobe Acrobat.
• 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

Job Type: Full-time

Pay: $40,000.00 - $60,000.00 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

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

Pay: $45,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $40,000 - $60,000