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Regulatory Compliance Associate

Aequor Technologies LLC

This is a Contract position in Dana Point, CA posted July 21, 2022.

Job Description: Key responsibilities: Act as core team member responsible for coordinating and identifying Regulatory and Compliance Remediation activity plans related to product transfer.

Basic Qualifications and Skills needed
• Degree in Science or Engineering based discipline, laboratory experience a plus
• Familiarity with Change Management requirements, and Processes related to Compendial methods remediation, validation/qualification for manufacturing, and Quality and technical risk management tools.

• Relevant Drug Product Technical Experience related to processing and manufacturing pharmaceutical products.

• Excellent Communication and presentation skills.

• Relevant experience with manufacturing operations for Sterile Injectable Drug Products.

• Relevant skills to gathering data from multiple sources and summarizing into simple, well organized documents
• Ability to be flexible and manage multiple deadlines
• Work independent to meet deadlines within team goals
• Documentum, Doc-U Sign and Track-wise experience preferred Position Comments visible to MSP and Supplier: Intake Notes:
• General understanding of change control
– required
• Documents review
– required
• Process Validation
– nice to have
• Laboratory experience
– nice to have
• 1-3 years of experience; needs to be able to identify gaps.

• Remote with some On-Site (candidate will need flexibility)
• BS Degree is required