Biologics Quality Assurance Specialist
Company: Actalent
Location: Westerville
Posted on: February 20, 2026
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Job Description:
Job Description Job Description Biologics Quality Assurance
Specialist INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO
MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA AT 330. 397. 1302
TO SET UP A PHONE INTERVIEW! ? Job Description The Quality
Assurance (QA) Auditor provides compliance and quality improvement
support to the manufacture of phase 1/2a Investigational New Drug,
Biologics manufacture, and facility operations. This role
collaborates with the Quality Assurance Manager to plan, schedule,
and conduct audits and administrative tasks to support the quality
management program. The position ensures compliance with applicable
regulations, policies, procedures, and expectations of
phase-appropriate current Good Manufacturing Practices (cGMP). The
QA Auditor I will also engage in various quality improvement and
process improvement initiatives. Responsibilities Operate within
the Quality Management Systems applicable to Investigational New
Drugs and Good Tissue Practices. Maintain a current knowledge of
applicable phase-appropriate FDA and International cGMP regulations
for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
Lead data review processes to facilitate biologic IND product
release. Perform GMP and Good Documentation Practices training for
manufacturing and support personnel. Lead QA functions related to
the Quality programs, such as process and laboratory audits,
protocol approvals, etc., as assigned. Coordinate with Biologics
Manufacturing Operations and QA Manager to perform vendor facility
audits. Support the QA Manager in mentoring and training QA staff
as needed. Assist the QA Manager during client and regulatory
audits, as well as client audits for records review. Manage,
review, and approve controlled documents necessary for the
effective functioning of biologics manufacture and good tissue
practices. Provide additional support to the Quality Assurance
Manager as required. Essential Skills Bachelor's degree in a
scientific discipline with a minimum of 1-2 years of quality or
regulatory experience. Knowledge and expertise in the principles of
Pharmaceutical Good Manufacturing Practices (GMP) or GLP.
Proficiency in Microsoft Office Suite, SharePoint, and Quality
Management Systems. Prior experience conducting audits and
technical writing. Ability to guide and train QA staff in various
tasks. Ability to travel for vendor/supplier audits and trainings
(approximately 15%). Strong interpersonal, organizational, and
leadership skills. Capability to handle multiple tasks
simultaneously in a growing department. Additional Skills &
Qualifications Experience with cell therapy, research, flow
cytometry, and tissue culture. Work Environment The work
environment is team-oriented, consisting of a diverse group of
individuals. The current team is around four people but
collaborates with several other teams, totaling approximately 23
people, with plans to expand by the end of the year. The role
requires strong teamwork skills, as no work or testing is conducted
in isolation. The position operates on a first shift schedule from
Monday to Friday, 8:00 AM to 4:30 PM, with occasional overtime Job
Type & Location This is a Contract to Hire position based out of
Columbus, OH. Pay and Benefits The pay range for this position is
$28.00 - $28.00/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 Columbus,OH.
Application Deadline This position is anticipated to close on Feb
27, 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, Dayton , Biologics Quality Assurance Specialist, Science, Research & Development , Westerville, Ohio
