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Qa Ra Associate Jobs (NOW HIRING)

AMRI

Senior Quality Assurance Specialist

Rensselaer, NY · On-site

$103K - $129K/yr

Minimum 8 years QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA regulated facilities * Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR ...

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How much do qa ra associate jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for qa ra associate in the United States is $26.48, according to ZipRecruiter salary data. Most workers in this role earn between $22.12 and $29.57 per hour, depending on experience, location, and employer.

What is a QA RA associate?

QA RA Associates, or Quality Assurance and Regulatory Affairs Associates, are professionals who help ensure that products—especially in industries like pharmaceuticals, medical devices, and biotechnology—meet quality standards and comply with government regulations. They assist in preparing and maintaining documentation, support audits, and help with the submission of regulatory filings. Their work is essential to keeping products safe, effective, and legally approved for market. QA RA Associates typically collaborate with various departments to ensure compliance throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a QA RA associate?

To thrive as a QA/RA Associate, you need a solid understanding of quality assurance and regulatory affairs principles, typically supported by a degree in life sciences or engineering. Familiarity with regulatory standards like ISO 13485, FDA 21 CFR Part 820, and proficiency in document control systems are essential. Strong attention to detail, analytical thinking, and effective communication skills help ensure compliance and facilitate cross-functional collaboration. These skills are crucial for maintaining regulatory compliance and ensuring product quality in highly regulated industries.

What are some typical challenges faced by a QA RA associate when navigating regulatory submissions?

QA RA Associates often encounter challenges such as staying updated with evolving regulatory requirements, coordinating documentation across departments, and ensuring submission accuracy. Managing tight deadlines while maintaining high-quality standards can be demanding, especially when multiple products or markets are involved. Successful associates proactively communicate with cross-functional teams and utilize strong organizational skills to streamline the submission process.

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Infographic showing various Qa Ra Associate job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 68% Full Time, 28% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $55,080 per year, or $26.5 per hour.

QA RA Director Consulting Position

Charleston, WV • On-site

ProPharma Group
Business Management Consulting • 51 - 200 employees
Learn more about ProPharma Groupexternal

Full-time

Posted 27 days ago

Key responsibilities

  • Assess draft platform roadmaps, identify gaps, and recommend lead platforms to build a phased, gated GMP readiness plan.

  • Guide and help execute design controls, FMEA, and IQ/OQ/PQ strategies for combined instrument, consumable, and software systems, including documentation if needed.

  • Advise on the development and refinement of the 21 CFR Part 11 roadmap, including decision-making on offline versus cloud-based analysis.

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

Our Biologics client builds instruments, software, hardware consumables, and biological consumables for functional cell-based assays. They have a lean team in need of an experienced strategic advisor to help build out and execute their GMP readiness plan so their first GMP-ready product can reach customers sooner and more efficiently

GMP Platform roadmap

  • Assess our draft 3-platform roadmap, gaps, timelines, and risks
  • Recommend which platform to lead with
  • Build a phased, gated roadmap with a defensible "launch line" for when it can credibly be sold for GMP use
  • Guide (and where needed help execute) design controls, design FMEA, and an IQ/OQ/PQ strategy for a combined instrument, consumable, and software system
  • (Possible) hand-on building of DQ/IQ/OQ/PQ documentation

21 CFR Part 11 roadmap

  • Review & refine our existing Part 11 roadmap
  • Advise as needed on Part 11 execution plans
  • Provide critical input into decision of offline versus cloud-based analysis

QMS Build-out - Instruments, HW Consumables, Biological Consumables, Software

  • Guide a lean QMS spanning all four product elements
  • Address the quality manual, SOPs, document control, supplier qualification, COAs, and how to handle batch-to-batch consumable variability and single-source component risk
  • Choose eQMS (or direct DIY eQMS)
  • (Possible) hands-on implementation of QMS and its elements (e.g. drafting SOPs, etc)

Organizational Quality Strategy

  • Help determine org strategy for scaling Quality & Regulatory function (identify key remaining gaps; map out which hires to make when; internal vs external support)
  • (Possible) Customer-facing Quality & Regulatory leader
  • Lending credibility to Quality & Regulatory strategy for customers considering investing in our platform prior to GMP-readiness
  • Engage with customers to gather critical VoC inputs to GMP-readiness

Requirements:

  • 10+ years in quality, regulatory, or GxP leadership within life sciences
  • GMP (21 CFR 211), 21 CFR 11, ISO 9001,eQMS implementation
  • Has built quality systems from the ground up - ideally for startups
  • Understands how drug manufacturers qualify and adopt supplier technologies for GMP workflows
  • Led QA for GMP drug manufacturer, has qualified vendor analytical assays
  • Vendor-side, taking scientific instruments from R&D into GMP-ready state for pharma/biotech customers.
  • Uses right-sized approach (i.e. lean where appropriate; careful not to overbuild)
  • Experience supporting products that combine instrumentation, software, biological consumables, and hardware consumables.

#LI-JH1#LI-ONSITE

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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