Quality Assurance Compliance Associate

Position: Quality Assurance Compliance Associate I/II

We are seeking a self-motivated team player with attention to detail, who enjoys organizing, process improvement, and making a difference in patient lives. The successful candidate will serve an essential role in supporting clinical product launch and production. This includes archiving and managing companywide GXP controlled documentation. The Quality Assurance Compliance Associate partners with cross-functional stakeholders to ensure the effectiveness of the Quality Management System (QMS). This position ensures and maintains the compliance quality system processes including but not limited to: Supplier Quality Management; Document Control; Quality Events Management (NCPs, Deviations, CAPA, etc.); and Good Manufacturing Practice (GMP)/QMS Training.

The candidate will collaborate with other internal teams to respond to change orders and document management system requirements. Completes all work in accordance with Capricor Quality Management Systems.

Knowledge of standard processes involved in document control and experience in an FDA regulated environment is required. The position will report to the Quality Assurance Compliance Supervisor.

Responsibilities:

• Under general supervision implement and maintain the document control system to ensure compliance with regulatory standards.
• Manage the life cycle of documents, including creation, review, revision, and obsoletion.
• Collaborate with various departments to develop and update standard operating procedures (SOPs), work instructions, and policies.
• Coordinate and monitor training activities for new and existing employees.
• Quality Management Systems: Develops, collects, trends, analyzes, reviews, and publishes quality metrics.
• Quality Events: Coordinates and administers quality event activities to ensure closure by due date. Processing activities include, but are not limited to, the preparation of agendas and presentations, managing meeting logistics, and generation/review of meeting minutes. Collaborates with quality event owners to process documentation both in the QMS as well as paper based documentation.
• Collaborate and partner effectively with Functional Leaders and lead the development of comprehensive curricula, aligning with organizational goals..
• Additional tasks as needed.

Requirements:

• A minimum of a Bachelor’s Degree with 2+ years of experience in a cGMP environment, preferably in quality compliance.
• Proven experience in document control, training, and aseptic processing within the biotech/pharmaceutical or other regulated industry.
• Knowledge of FDA, ICH and EMA regulatory requirements specific to document control and training.
• Excellent record-keeping, attention to detail, and organizational skills.
• Proficient in Microsoft Office (Word, Excel, Visio, Access), Adobe suite, and various database systems.
• Strong verbal and written communication skills.
• Familiarity with Quality Management Systems (QMS) and record management in a cGMP setting.
• Exceptional problem-solving abilities and skill in managing multiple tasks simultaneously.
• Effective communication accross different functional groups.
• Results-driven, with a focus on compliance.
• Demonstrates strong initiative and follow-through.
• Comfortable in a fast-paced and dynamic work environment.

Travel Requirements:

Work Environment / Physical Demands:

• Must be able to sit and stand for extended periods.
• Must be able to lift / carry reports and materials up to 40 pounds, move about the office.
• Communicate efficiently and effectively via virtual, in-person or over the phone, and complete required paperwork.
• Able to fully gown and work in an ISO 7 manufacturing area.