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 Quality Assurance Specialist responsible for performing quality assurance review and disposition of compounded sterile drug products in compliance with FDA 503B, GDP, and cGMP standards. The role ensures all batches meet established quality, regulatory, and documentation requirements prior to release for distribution and supports label reconciliation/verification and visual inspections/AQLs.

Key Responsibilities

• Perform comprehensive review of batch records and related documentation to ensure product quality and compliance.
• Verify that manufacturing, testing, and labeling activities were completed according to approved SOPs (Standard Operating Procedures) and MBRs (Master Batch Records).
• Conduct in-process documentation reviews and ensure GDP (Good Documentation Practices) are maintained.
• Collaborate closely with QC, Production, Operations, etc. to resolve discrepancies and ensure batch readiness for release.
• Support regulatory inspections, internal audits, and mock audits as needed.
• Assist in change control, risk assessment, and process improvement initiatives impacting product release.
• Maintain up-to-date knowledge of FDA 503B, cGMP, and other related requirements.
• Retrieve, quarantine, and deliver batch records/finished goods.
• Collaborate with QC on the review of test results for product release.
• Complete all necessary documentation to ensure it is completed for GMP documents in real time.
• Follow best practices and regulatory requirements.
• Other assigned tasks as requested by management.

Qualifications

• Have a keen eye for detail.
• Knowledgeable about batch release.
• GDP experience.
• Works at a good pace.

Preferred: Experience in Visual Inspections would be advantageous but not necessary.

Schedule/Shift

1st shift (7am-4:30pm, Monday through 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

In accordance with applicable law, Medix will provide reasonable accommodations for qualified applicants and associates with disabilities. If you have a disability and believe you may require an accommodation, please contact your recruiter for assistance.

^*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.

^*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.