QUALITY COMPLIANCE ASSOCIATE 1 or 2 - Capricor Inc
San Diego, CA 92121
About the Job
Position: Quality Compliance Associate I - II
Capricor is seeking a self-motivated team player who is meticulous and has a keen eye for detail. The successful candidate should have a knack for organization, a drive for improving processes, and a desire to make a difference in patient lives. The selected candidate will serve an essential role in supporting commercial product launch and production. Responsibilities include batch record review, deviation investigation, label issuance, and tracking, issuing, distributing, and archiving companywide GLP / GCP / GMP controlled documentation, training, and facility support systems.
Responsibilities:
- Support Regulatory Inspection readiness across two sites.
- Creating training program for inspection readiness
- Support global teams between two sites with:
- Global Change Control Management
- Global Deviation/CAPA Management
- Support Global document control activities, including defining appropriate corporate policies and workflows.
- Support final product specifications across two sites.
- Working knowledge of 21 CFR 210 and 211, 600, ICH, ISO9001, EU Guidelines and other relevant FDA regulations is a must.
- Conduct review of completed deviations, corrective and preventative actions (CAPA), change controls, training, and internal audits. Write associated reports, provide feedback to the appropriate owners.
- Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system.
- Collaborate on the development, improvement, of the quality management systems, as assigned.
- Write and/or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices.
- Support regulatory/submission activities.
- Ability to participate and prepare relevant materials for Management Review and Material Review Board meetings.
- Performs other duties as assigned
Requirements:
- Bachelor’s Degree with 5+ years of experience in cGMP environment, with supervisory experience is required.
- Experience in commercial cell therapy company is highly desired.
- Experience in Aseptic Processing is a plus.
- Attention to detail and excellent record-keeping skills.
- Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems.
- Good oral and strong written communication skills.
- Familiarity with Quality Systems and records management in a cGMP environment.
- Strong problem-solving skills and the ability to coordinate and perform multiple activities.
- Results-oriented with dedication to compliance and customer service.
- Strong initiative, independence and follow-through.
- Comfortable working in a fast-paced, cross functional team and dynamic environment.
- Comfortable dealing with rapidly changing priorities.
- Aseptic processing a plus.
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 on the telephone or in person, and complete required paperwork.
- Work extended or off hours depending on the company needs to respond to manufacturing schedule, equipment alarms (including weekends, holidays).
PI251630374