Quality Assurance Associate

Job Title: Quality Assurance Associate

Job Description

The Quality Assurance (QA) Technician supports the quality systems and compliance activities in our 503B sterile compounding facility. This role is critical in ensuring that all products are manufactured in accordance with cGMP and FDA 503B regulations. The QA Technician will assist with environmental monitoring of cleanrooms, track and document any deviations from processes, manage document control and batch record reviews, and participate in investigations and corrective actions for quality issues. This position works closely with the QA/QC department and manufacturing team to maintain the highest standards of product quality, safety, and regulatory compliance in the facility.

Responsibilities

• Assist with environmental monitoring of cleanrooms.
• Track and document any deviations from processes.
• Manage document control and batch record reviews.
• Participate in investigations and corrective actions for quality issues.
• Work closely with the QA/QC department and manufacturing team.
• Communicate quality-related information effectively to operations staff.
• Provide training or guidance to production personnel on quality procedures.

Essential Skills

• 3 years of QA experience in a sterile compounding facility.
• Strong knowledge of FDA cGMP regulations, USP standards for compounding, and 21 CFR Part 210/211 requirements.
• Experience with quality management systems including deviation/CAPA management, document control, change control, and batch record review.
• Proficiency in using office software (e.g., Word, Excel) and possibly electronic quality management tools.

Additional Skills & Qualifications

• Bachelor’s degree in a relevant scientific or healthcare field (e.g., Pharmacy, Chemistry, Biology, Microbiology) is preferred.
• Candidates with an Associate’s degree and significant relevant experience may also be considered.
• Ongoing education or certifications in quality assurance or regulatory compliance are a plus.
• Experience working in an FDA 503B outsourcing facility or sterile compounding pharmacy is highly desirable.

Work Environment

The work environment is a clean room setting where garbing and PPE are required. The schedule is Monday through Friday, 9 am to 5 pm. This position is the first hire in a startup environment with plans for rapid expansion and advancement opportunities. The facility is an FDA-registered 503B outsourcing facility specializing in sterile compounded medications for critical care settings, operating under strict cGMP and regulatory oversight. Located in Albany, NY.

Job Type & Location

This position based out of Colonie, New York.

Pay and Benefits

The pay range for this position is $25.00 - $50.00/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 Colonie,NY.

Application Deadline

This position is anticipated to close on Nov 7, 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 for other accommodation options.

Salary : $25 - $50