Quality Assurance​/Batch Release Specialist

Description

Under general supervision, the Quality Assurance Batch Release Specialist is responsible for ensuring the compliance of all batch records and release of products for operations and shipments. The Quality Specialist also coordinates with internal teams and external labs to ensure batch record information for accuracy and legibility per current good manufacturing processes. In addition, the role will interact with clients and customer quality teams, on a routine basis, to provide release information and create the certificates of analysis.

The Quality Assurance Release Batch Specialist reports the status of all projects and initiatives to the Quality Assurance Manager.

• Ensures compliance with cGMP, Company SOPs and FDA requirements during all phases of operations.
• Issuance, assembly and auditing of batch records to assure all regulatory and internal requirements for the product quality.
• Completes final review of batch records prior to release of product.
• Creates certificates of analysis.
• Reviews all batch records for compliance and acceptance.
• Ensures corrections to batch records and completion.
• Coordinates with quality inspectors and production teams daily for GDP compliance of documentation.
• Releases Bulk for operations including documentation and system transactions as assigned.
• Releases Finished Good products for shipment including documentation and system transactions.
• Communicates with Clients and Customer Quality regarding product record discrepancies and release status.
• Maintains metrics and data, as required, for Quality.
• Maintains and organizes finalized batch records ensuring accurate documentation and timely completion of all filing activities.
• Provides backup support for document controls, (DCA & Filing) Quality Inspections in filling and compounding, as needed.
• Other duties, as assigned, by the manager.

• Quality control
• Quality assurance
• Batch record
• Batch record review
• Batch release
• GMP

• Bachelor Degree, or equivalent work experience.
• 1-2 years of experience in FDA regulated business.
• 1-2 years GDP Experience/Training.
• Knowledge of ISO 13485 and or ISO 9001.
• Knowledge of QSR for Medical Devices.

Intermediate Level

This is a Contract position based out of Dallas, TX.

The pay range for this position is $24.61 - $27.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Dallas,TX.

This position is anticipated to close on Mar 4, 2026.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom