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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 ...

SNAP Diagnostics

RA QA SPECIALIST

Vernon Hills, IL · On-site

$65K - $85K/yr

Bachelor's Degree Preferred We are seeking a detail-oriented and experienced Quality Assurance Specialist to support quality operations and compliance initiatives in a regulated environment. This ...

Werfen

Quality Specialist III - WI

Waukesha, WI · On-site

Job Information Number ICIMS-2026-10768 Job function QA&RA Job type Full-time Location Werfen - Waukesha - Waukesha, Wisconsin United States Country United States Shift 1st About the Position ...

Procom Consultants Group

QA Tester

Milwaukee, WI

Work with RA IT and Marketing to create Testing scripts for User Acceptance Testing * Setup and ... QA Tester Start Date ASAP QA Tester Assignment Length 6+ months Additional Information All your ...

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How much do qa ra jobs pay per year?

As of Sep 8, 2026, the average yearly pay for qa ra in the United States is $124,124.00, according to ZipRecruiter salary data. Most workers in this role earn between $102,000.00 and $137,500.00 per year, depending on experience, location, and employer.

What is a QA/RA professional?

QA/RA professionals are experts in Quality Assurance (QA) and Regulatory Affairs (RA), typically within industries such as pharmaceuticals, medical devices, and biotechnology. QA focuses on maintaining product quality and compliance with internal and external standards, while RA ensures that products meet all regulatory requirements set by government agencies. Together, these professionals help organizations navigate complex regulations, prepare documentation for approvals, and ensure ongoing compliance throughout the product lifecycle.

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

To thrive as a QA/RA professional, you need a solid background in quality management systems, regulatory guidelines, and industry standards, often supported by a relevant science or engineering degree. Familiarity with regulatory submission software, document control systems, and certifications such as ASQ or RAC is highly valued. Attention to detail, strong analytical thinking, and effective communication are crucial soft skills for interpreting regulations and collaborating with cross-functional teams. These skills ensure product compliance, minimize regulatory risks, and support the successful launch of safe, effective products.

What are some common challenges faced by QA/RA professionals, and how can they be effectively managed?

QA/RA professionals often encounter challenges such as keeping up with frequently changing regulations, managing documentation for compliance audits, and coordinating across departments to ensure product quality and regulatory alignment. Staying current with industry standards and regulatory updates is crucial, as is developing strong organizational and communication skills to facilitate collaboration. Leveraging specialized software tools and participating in ongoing professional development can help manage these complexities and ensure both compliance and product quality.

Is QA a stressful job?

Quality Assurance (QA) roles can be stressful at times due to tight deadlines, the need for attention to detail, and the responsibility of identifying and resolving defects. However, the level of stress varies depending on the company, project complexity, and individual workload management. Good organizational skills and experience with testing tools can help reduce stress in QA jobs.
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Qa Ra jobs near you
Infographic showing various Qa Ra job openings in the United States as of September 2026, with employment types broken down into 84% Full Time, 8% Part Time, and 8% Nights. Highlights an 92% In-person, and 8% Remote job distribution, with an average salary of $124,124 per year, or $59.7 per hour.

Senior Specialist, GMP Quality Assurance

Waltham, MA • On-site

Kailera Therapeutics, Inc.
See more jobs at Kailera Therapeutics, Inc.external

$89K - $122K/yr

Full-time

Re-posted 3 days ago

Job description

What You'll Do:

The Senior Specialist, GMP Quality Assurance will collaborate internally with QA, RA, and CMC departments. As needed, work with external Approved Service Providers to ensure oversight and compliance. The Senior Specialist will perform review of drug substance/drug product manufacturing records and associated documents (i.e. deviations) for product that will be released for use in Kailera phase I-III clinical programs. The Senior Specialist will help continuously improve Quality System Procedures related to GMP activities related to their function and will collaborate closely with internal cross-functional teams.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

  • Review and approve Service Provider GMP documentation
  • Review and approve master batch/packaging records
  • Review executed batch/packaging records for Intermediates, Drug Substance, and Drug Product
  • Prepare batch file for final batch disposition for Kailera's Phase I-III clinical programs
  • Review GMP Quality Events, change controls, CAPA's, and other GMP documentation as needed
  • Identify and escalate issues effectively
  • Compile data for Quality System Reviews
  • Evaluate GMP activities for continuous improvement opportunities
  • Support creation and continuous improvement of Kailera procedures
  • Other Quality Assurance responsibilities as assigned

Required Qualifications:

  • 6+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
  • Understanding and knowledge of industry standards, concepts, current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex), and other agency standards and guidance as they relate to quality systems/quality assurance
  • Experience with review of GMP manufacturing/packing records (Master/Executed Batch Records, Deviations, Change Controls, etc.) associated with Phase I-III clinical studies
  • Proficient in Veeva QualityDocs and Veeva QMS a plus
  • Demonstrates proven track record of communication with internal and external Service providers
  • Ability to identify quality issues requiring escalation
  • Clear, concise writing skills and good verbal presentation skills
  • Self-motivated, detail oriented, well organized, and able to manage multiple projects
  • Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Service providers in a professional and collaborative manner

Preferred Qualifications:

  • Biotech experience preferred

Education:

  • BA or BS degree in a scientific discipline or supplemental Quality education

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