Quality Assurance Associate

EEO Employer - Disability/Vet

*Reasonable accommodations can be made to those with disabilities

This position requires access to ITAR-controlled technical data and/or EAR-controlled technology. The hiring process for this position will therefore include an export compliance assessment, which will include an assessment of U.S. person status. U.S. persons are defined by 22 CFR 120.62 and 15 CFR 772.1 to include U.S. citizens, U.S. permanent residents, and people with asylee or refugee status.

Why Join Us

Join a collaborative team of scientists, engineers, and quality professionals supporting chemical process development in the fine chemical and pharmaceutical industries. At Nalas Engineering, you’ll help ensure high-quality laboratory and manufacturing operations while gaining hands-on experience and contributing to projects that drive real innovation and company growth.

Benefits: Nalas provides a 6% company-matched 401(k) fully vested on day one, a $0‑deductible health insurance plan, and more! Additional wellness, dental, and vision options are available to support employees and their families.

Scope: Nalas recognizes that our employees are our greatest asset. To this, we are committed to provide a dynamic environment where employees can grow, thrive and make a difference. We adhere to a strict commitment to our values of Safety, Integrity, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity and consider joining a dynamic team in a fast-growing company.

Position Overview

The Quality Assurance Associate is responsible for devoting their time to support, maintenance, and continual improvement of the Quality Management System (QMS). This associate will support the monitoring of the organization’s compliance with QMS requirements (International Organization for Standardization ISO 9001:2015).

The Quality Assurance Associate assists in the development and/or revision, implementation, and maintenance of policies, SOPs, and forms to ensure compliance with all current and applicable regulatory requirements or guidelines. They will perform accurate data entry, documentation, and QMS narrative creation.

Primary Responsibilities

Qualifications

· Bachelor’s degree or has a minimum of 2 years of related work experience in the fine chemical, pharmaceutical, or manufacturing regulated environment in a Quality Assurance capacity

· Knowledge of ISO 9001, FDA 21 CFR 211, ICH, or Good Manufacturing Practices (cGMPs), and pertinent related compliance regulations and guidance

· Knowledge and application of good documentation practices and solid computer skills using Microsoft Suite

· Exhibits excellent organizational, verbal, and technical written communication skills

· Exhibits excellent interpersonal skills and the ability to work in a team environment

· Executes multiple tasks effectively and concurrently while able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency to ensure all requirements are met

Technical Contributions

· Skilled in the practice and enforcement of Good Documentation Practices (GDP)

· Become proficient at leading Quality Management System (QMS) training and tracking training completion

· Become proficient in Vendor Management and Approval Process

· Maintains and supports progression of CAPAs and NCRs

Lab Proficiency

· Performs documentation review of batch history record, laboratory notebooks, and associated product related documentation, as needed

· Assists in the control and management of the calibration and maintenance programs

· Supports manufacturing documentation efforts, as needed

Customer Facing Contributions

· Supports internal, vendor, customer and third-party audits and associated follow-through, as needed

Project Management

· Collaborate with other teams

· Supports document control activities and material traceability activities

· Works closely under quality lead to support vendor qualification programs

Conditions of Employment

· US Person

· Drug Screening

· Background Check

· Valid driver’s license

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Pay: $63,700.00 - $88,300.00 per year

Benefits:

• 401(k) matching

• Dental insurance

• Flexible schedule

• Life insurance

• Paid time off

• Retirement plan

• Vision insurance

Application Question(s):

• This position requires access to ITAR-controlled technical data and/or EAR-controlled technology. The hiring process for this position will therefore include an export compliance assessment, which will include an assessment of U.S. person status. U.S. persons are defined by 22 CFR 120.62 and 15 CFR 772.1 to include U.S. citizens, U.S. permanent residents, and people with asylee or refugee status. (PLEASE RESPOND WITH YOUR STATUS)

For Export compliance purposes, what is your status from the below?

Work Location: In person