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 Compliance Coordinator to manage and address a large compliance gap by efficiently collating necessary documents from suppliers, retrieving drug master file numbers, and conducting supplier education. The role involves reviewing incoming documents, making changes to control documentation, and preparing documents for audits, primarily through communication with suppliers.

Key Responsibilities

• Collect documents from suppliers and retrieve drug master file numbers.
• Educate suppliers on compliance requirements.
• Review documents and data from suppliers.
• Make necessary changes to control documentation.
• Prepare documents for audits.

Qualifications

• 2+ years of Pharma or Device GMP experience.
• Familiarity with ALCOA.
• Experience in Change Control and/or Supplier Quality.
• Experience in Risk Assessment, Vendor Management, and Vendor Scorecard.

Skills

• Technical skills in change control and supplier quality management.
• Strong communication skills for effective supplier education and document retrieval.

Additional Requirements

• This role can be remote with flexible hours.
• 1st shift: 8:30am-5pm, Monday to Friday.

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

Employment eligibility to work with our client in the U.S. is required as the company will not pursue visa sponsorship for these positions.

^*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.

Any required state or Joint Commission training is compensated at the state or local minimum wage rate.

^*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. 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.