QA TECHNICIAN

Department: Quality Assurance

Reports To: R&Q Group Director

Mission:

Strengthen, promote and capitalize on our client's competitive advantages by ensuring high-quality APIs are delivered to the market, making quality a core priority across all operations.

Responsibilities:

Provide direct support to the R&Q Group Director at subsidiary level on all Quality Assurance activities.
Ensure consistent quality of materials and supporting documentation delivered to customers by enforcing Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and compliance with all applicable federal, state and municipal regulations.
Establish and maintain strong working relationships with regulatory agencies and authorities on behalf of or client, partner companies and key stakeholders.
Act as the primary local Quality contact for third-party logistics providers and clients, and as the qualified person for internal quality compliance matters.
Liaise with customers and regulatory authorities on quality-related topics, including hosting inspections and responding to observations.
Review and evaluate documentation received from manufacturers and suppliers, including company information, certifications and product data.
Supervise product reception to ensure compliance with approved specifications and authorize release for storage, or verify that subcontracted activities are performed according to the company’s quality standards.
Prepare, update and maintain product documentation such as Certificates of Analysis, Technical Packs, Declarations, Statements and MSDS.
Respond to questionnaires and requests for additional information from customers and authorities.
Review processing and batch records to support product shipment release and ensure proper record keeping.
Ensure knowledge, implementation and adherence to Quality SOPs, regulations and guidelines across operations.
Ensure supplier regulatory listings and records are correctly maintained, including NDC, IOR and FEI.
Participate in and lead public and private audits in collaboration with the R&Q Group Director and external stakeholders.
Support interactions with Health Authorities to understand requirements for importation and sale of products.
Support the logistics team in importation processes and collaborate in the company’s Supplier Qualification Program.
Develop, update, review and implement standard operating procedures for the QA department and the subsidiary in alignment with global standards and the local Quality System.
Perform periodic internal audits and audits of external warehouses.
Monitor quality aspects of warehousing practices to ensure compliance with approved procedures.
Manage product complaints in accordance with internal processes.
Track and analyse audit data to identify systemic issues, compliance risks and process improvement opportunities, and support the definition and implementation of CAPAs and continuous improvement initiatives.
Ensure clear, timely and structured communication with supervisors and the commercial team.
Maintain quality documentation updated within internal computer systems.
Enter and manage regulatory information for assigned projects in Registration Tracking databases and systems within the global RA group in Madrid.
Support training initiatives on GDP and GMP for new employees and collaborate in the development of interdepartmental technical training plans.

Job Requirements

Minimum 3 years of professional experience within pharmaceutical companies.
1–2+ years of experience in a Quality Assurance, Quality Operations, or similar role within pharmaceutical API distribution or trading environments is highly desirable, but could come from manufacturing, distribution, trading, or pharmacy environments.
Solid understanding of GDP requirements and basic knowledge of GMP, particularly as applied to warehouses, logistics, and product release.
Hands-on experience reviewing and managing quality documentation such as COAs, MSDS, Technical Packs, Declarations, and related compliance documents.
Ability to work in a highly operational, on-site role, closely linked to warehouse activities, product reception, and storage.
Strong decision-making skills with the confidence to say no when quality risks exist, while proposing compliant, business‑oriented alternatives.
Comfortable interacting with supply chain and commercial teams, maintaining clear separation of duties while supporting business continuity.
Exposure to audits, inspections, or regulatory interactions (FDA, DEA, or equivalent authorities) is a strong plus.
Fluent English is mandatory; Spanish is a strong advantage.
Proactive, hands-on professional with autonomy, energy, and a strong sense of ownership.
Willingness and availability to work on-site in New Jersey, with very limited remote work.

About the company:

The company is headquartered in Spain and it operates globally across 70+ countries, with over 400 customers, and a strong presence in the U.S. market since 1999. Focused on APIs and the CDMO ecosystem, the company acts as a long‑term partner to pharmaceutical clients, combining global scale with an agile, non‑bureaucratic culture. While European in origin, it has built solid credibility in the U.S., operating under top global quality standards and full FDA compliance.They value hands‑on professionals with autonomy, an entrepreneurial mindset, and a strong drive to create impact close to the business.

About MCR International

We’re excited to connect with professionals who are truly aligned with this opportunity. Before you apply, please take a moment to review the following:

Please only apply if your experience and qualifications match what’s outlined in the job description. We want to make sure your time and ours is well spent.
Make sure your contact details—especially your phone number and email—are accurate and complete so we can reach you easily if your profile is a match.
This role is being managed by MCR International, a recruiting firm. We kindly ask that other recruiting or staffing agencies do not submit candidates for this position.
You must be authorized to work in the U.S. without the need for visa sponsorship.

Job Type: Full-time

Pay: From $60,000.00 per year

Application Question(s):

What is your exposure to Quality, Compliance, or regulated activities (QA, GDP/GMP, documentation, audits, product release, etc.)?
Have you worked in an operational or warehouse‑based environment
Are you able and willing to work on‑site in New Jersey in a hands‑on, operational role (limited remote work)?
What best describes your approach to Quality decisions?
What is your current salary?
What is your desired salary?

Experience: