Quality Assurance Specialist

Job Description Under general supervision, the Quality Assurance Batch Release Specialist ensures the compliance of all batch records and oversees the release of products for operations and shipments. The specialist works closely with internal teams and external labs to verify batch record information for accuracy and legibility in accordance with current good manufacturing practices. Additionally, the role involves routine interaction with clients and customer quality teams to provide release information and create certificates of analysis. The specialist reports the status of all 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 meet 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 batch records and completion. + Coordinate daily with quality inspectors and production teams for GDP documentation compliance. + Release Bulk for operations, including documentation and system transactions. + Release Finished Good products for shipment, including documentation and system transactions. + Communicate with clients and customer quality regarding product record discrepancies and release status. + Maintain metrics and data, as required, for Quality. + 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 + Quality control + Quality assurance + Batch record review + Batch release + GMP + Certificates of Analysis Additional Skills & Qualifications + Bachelor Degree or equivalent work experience. + 1-2 years of experience in FDA regulated business. + 1-2 years of GDP Experience/Training. + Knowledge of ISO and/or ISO 9001. + Knowledge of QSR for Medical Devices. Work Environment The role involves working in a regulated environment that adheres to FDA guidelines. The specialist must collaborate with various teams and external partners, ensuring compliance with quality standards and maintaining accurate documentation. The position requires attention to detail and the ability to manage multiple tasks efficiently. Job Type & Location This is a Contract to Hire position based out of Dallas, TX. 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 Apr 6, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-04-02