Quality Assurance / Batch Release Specialist

Job Title : Quality Assurance / Batch Release SpecialistJob Description

Under general supervision, the Quality Assurance Batch Release Specialist ensures compliance of all batch records and releases products for operations and shipments. The specialist coordinates with internal teams and external labs to ensure batch record accuracy and legibility per current good manufacturing practices. This role involves routine interaction with clients and customer quality teams to provide release information and create certificates of analysis. The Quality Assurance Release Batch Specialist reports the status of projects and initiatives to the Quality Assurance Manager.

Responsibilities

Ensure compliance with cGMP, company SOPs, and FDA requirements during all phases of operations.

Issue, assemble, and audit batch records to assure all regulatory and internal product quality requirements.

Complete final review of batch records prior to product release.

Create certificates of analysis.

Review all batch records for compliance and acceptance.

Ensure corrections to and completion of batch records.

Coordinate with quality inspectors and production teams daily for GDP compliance of documentation.

Release bulk for operations, including documentation and system transactions as assigned.

Release finished goods for shipment, including documentation and system transactions.

Communicate with clients and customer quality teams regarding product record discrepancies and release status.

Maintain metrics and data for quality as required.

Maintain and organize finalized batch records, ensuring accurate documentation and timely completion of all filing activities.

Provide backup support for document controls, quality inspections in filling and compounding, as needed.

Perform other duties as assigned by the manager.

Essential Skills

Experience in quality control, quality assurance, batch record review, and batch release.

Knowledge of GMP.

Bachelor's degree or equivalent work experience.

1-2 years of experience in an FDA-regulated business.

1-2 years of GDP experience or training.

Knowledge of ISO and / or ISO 9001.

Knowledge of QSR for medical devices.

Work Environment

The work environment requires compliance with good manufacturing practices and involves coordination with internal teams, external labs, and client quality teams. The specialist will work in a setting that emphasizes accuracy and documentation, ensuring compliance with regulatory and internal quality standards.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a fully onsite position in Dallas,TX.

Application Deadline

This position is anticipated to close on Oct 23, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.