# QA/RA Specialist

**Company:** [synergy](http://jobs.workable.com/companies/uAUhGzJJdLoH5dGyShRPEa.md)
**Location:** Dallas, United States
**Workplace:** on site
**Employment type:** Full-time
**Department:** Quality

[Apply for this job](http://jobs.workable.com/view/25b1380b-6338-45c9-b905-8bfbc9345994)

## Description

Synergy Bioscience is a pharmaceutical and biotech CRDMO providing development, manufacturing, testing, and regulatory compliance consulting services. Our work supports organizations navigating complex quality and regulatory demands across the product lifecycle, with a focus on maintaining rigorous standards in highly regulated environments.

As a QA/RA Specialist, you will play an important role in helping maintain the quality and regulatory foundation behind laboratory and manufacturing operations. This role is well suited to someone who brings strong judgment, a detail-oriented approach, and the ability to work across teams to support compliant, consistent, and effective quality systems.

### Responsibilities

-   Develop, review, and maintain quality assurance and regulatory affairs documentation in compliance with GLP and GMP standards.
-   Ensure adherence to regulatory requirements from FDA, EMA, and other global regulatory agencies.
-   Conduct internal audits and inspections to assess compliance with quality systems and regulatory standards.
-   Support preparation and management of regulatory submissions and responses to regulatory agencies.
-   Collaborate with cross-functional teams to ensure compliance throughout product lifecycle.
-   Assist in training laboratory and manufacturing staff on quality system requirements and regulatory standards.
-   Investigate and support resolution of deviations, non-conformances, and CAPA activities.

## Requirements

-   Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.
-   10+ years of QA/RA experience in pharmaceutical environments working under both GLP and GMP standards.
-   Strong knowledge of FDA, EMA, and ICH regulatory requirements.
-   Hands-on experience conducting internal audits and inspections, investigating deviations and non-conformances, and supporting CAPA activities.
-   Experience managing regulatory submissions and responses to regulatory agencies.
-   Proven ability to lead cross-functional compliance activities across the product lifecycle.
-   Experience training laboratory staff on quality system requirements and regulatory standards.

## Benefits

-   Health Care Plan (Medical, Dental & Vision)
-   Paid Time Off (Vacation, Sick & Public Holidays)
-   Training & Development