Quality Systems Associate I or II
1 day ago
Capricor Inc is seeking a highly motivated and detail-oriented Quality Systems Associate to support the development and maintenance of quality systems. The successful candidate will partner with cross-functional stakeholders to ensure the effectiveness of the Quality Management System (QMS).
The Quality Systems Associate will be responsible for implementing and maintaining the document control system, managing the life cycle of documents, and collaborating with various departments to develop and update standard operating procedures (SOPs), work instructions, and policies.
The ideal candidate will have a minimum of a Bachelor's Degree with 2+ years of experience in a cGMP environment, preferably in quality compliance. They will also have proven experience in document control, training, and aseptic processing within the biotech/pharmaceutical or other regulated industry.
The Quality Systems Associate will work closely with the Quality Systems Supervisor to ensure compliance with regulatory standards and support the development of comprehensive training curricula. They will also assist in continuous improvement initiatives and projects within the site's quality organization.
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 across 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:
- Up to 30% travel. Willing to travel between Capricor sites (Los Angeles and San Diego).
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.
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