QA/RA Specialist

Socket.dev; Dallas (TX); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Paid Time Off (Vacation, Sick &)

Job summary

Synergy Bioscience is seeking a QA/RA Specialist to strengthen the quality and regulatory foundation behind laboratory and manufacturing operations. The role requires strong judgement, attention to detail, and the ability to work across teams to support compliant, consistent quality systems.

Responsibilities include developing and maintaining QA/RA documentation to GLP and GMP standards; ensuring FDA/EMA/ICH compliance; conducting internal audits; supporting regulatory submissions; training

Qualifications

• Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
• 10+ years of QA/RA experience in pharmaceutical environments under GLP and GMP.
• Strong knowledge of FDA, EMA, and ICH regulatory requirements.
• Experience conducting internal audits and investigations of deviations and CAPA.
• Experience managing regulatory submissions and responses.
• Ability to lead cross-functional compliance across the product lifecycle.
• Experience training staff on quality system requirements.

Responsibilities

• Develop, review, and maintain QA and regulatory 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.

Skills

QA/RA experience

Regulatory knowledge

Auditing experience

Cross-functional collaboration

CAPA handling

Training staff

Education

Bachelor's degree in life sciences, pharmacy, chemistry, or 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 judgement, 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