Quality Assurance Specialist

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. This role ensures all batches meet established quality, regulatory, and documentation requirements prior to release for distribution. The position also supports label reconciliation, verification, and visual inspections.

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 and MBRs.
• Conduct in-process documentation reviews and maintain GDP standards.
• Collaborate with QC, Production, Operations 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.
• Maintain up-to-date knowledge of FDA 503B, cGMP, and 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 for GMP compliance in real time.
• Ensure best practices and regulatory requirements are followed.
• Perform other assigned tasks as requested by management.

Qualifications

• Experience with Batch release and Batch Record Review.
• GDP experience.
• Keen eye for detail and ability to work at a good pace.

Skills

• Batch release / Batch Record Review experience.
• Good Documentation Practices (GDP) knowledge.
• Detail-oriented and efficient work pace.
• Preferred experience in Visual Inspections.

Additional Requirements

• 1st shift: 7am-4:30pm, 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.

* 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.