Quality Assurance/ Batch Release Specialist
Company: Actalent
Location: Dallas
Posted on: February 20, 2026
|
|
|
Job Description:
Job Description Job Description 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. Essential Roles and Responsibilities: • 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. Skills Quality control, Quality assurance, Batch record,
Batch record review, batch release, GMP Top Skills Details Quality
control,Quality assurance,Batch record,Batch record review,batch
release,GMP Additional Skills & Qualifications Qualifications
Required Education, Certification & Experience: • Bachelor Degree,
or equivalent work experience. • 1-2 years of experience in FDA
regulated business. • 1-2 years GDP Experience/Training Required
Knowledge, Skills & Abilities: • Knowledge of ISO 13485 and or ISO
9001 • Knowledge of QSR for Medical Devices Experience Level
Intermediate Level Job Type & Location This is a Contract 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 Mar
4, 2026. 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 for other accommodation
options.
Keywords: Actalent, Dallas , Quality Assurance/ Batch Release Specialist, Science, Research & Development , Dallas, Texas
