QA/RA Specialist

Synergy; Dallas (TX); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health care plan

Paid time off

Training & development

Job summary

Synergy Bioscience is seeking a QA/RA Specialist to uphold quality and regulatory foundations across laboratory and manufacturing operations. You will bring strong judgment, attention to detail, and cross-functional collaboration to support compliant, effective quality systems.

The role emphasizes maintaining GLP/GMP standards, supporting regulatory submissions, and guiding CAPA processes, with a focus on FDA/EMA/ICH requirements and audits.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.
• 10+ years of QA/RA experience in pharmaceutical environments working under 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.

Responsibilities

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

Skills

QA/RA leadership

GLP/GMP knowledge

FDA/EMA/ICH knowledge

Internal audits

CAPA & deviations

Regulatory submissions

Cross-functional collaboration

Staff training

Education

Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field

Job 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.

• 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.

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