You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a dedicated Compliance Manager responsible for overseeing various compliance aspects to ensure the laboratory meets regulatory standards. This position focuses on maintaining accreditation, ensuring compliance with regulations, and overseeing documentation and training.

Key Responsibilities

• Maintain CAP/CLIA compliance by conducting regular audits and assessments.
• Strengthen GCLP, HIPAA, and GDPR compliance to secure patient data.
• Ensure compliance with GCLP regulations, especially for large molecule projects.
• Manage training files, ensuring all laboratory personnel are compliance-trained.
• Act as a Subject Matter Expert on client study compliance.
• Provide QA/QM support, identifying areas for improvement.
• Oversee proficiency testing programs to meet CAP standards.
• Manage compliance-related documentation, preferably using MediaLab.
• Ensure electronic records comply with 21 CFR Part 11 regulations.
• Implement and maintain encryption standards for laboratory data.
• Ensure systems comply with HIPAA, GDPR, and 21 CFR Part 11.
• Lead efforts to prepare for internal and external audits.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

Required Employment / Compliance Language

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.