QA/RA Specialist

synergy; Town of Texas (WI); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Paid Time Off (Vacation, Sick & Public

Training & Development

Job summary

Synergy Bioscience is seeking a QA/RA Specialist to uphold quality and regulatory foundations behind laboratory and manufacturing operations. The role suits someone with strong judgment, attention to detail, and cross-functional collaboration to support compliant, effective quality systems.

Responsibilities include maintaining QA and regulatory documentation, ensuring FDA/EMA/ICH compliance, conducting audits, and supporting submissions.

Qualifications

• Attention to detail is essential for maintaining quality systems and documentation.
• Strong regulatory knowledge across FDA, EMA, and ICH requirements.
• Hands-on experience conducting internal audits and inspections to ensure compliance.
• Experience managing regulatory submissions and responses to agencies.
• Proven ability to lead cross-functional compliance activities across the product lifecycle.
• Ability to train staff on quality system requirements and regulatory standards.
• Experience addressing deviations, CAPAs, and regulatory findings.

Responsibilities

• Maintain QA and regulatory documentation in line with GLP and GMP standards.
• Ensure adherence to FDA, EMA, and global regulatory requirements.
• Conduct internal audits and inspections for quality systems compliance.
• Prepare and manage regulatory submissions and responses to agencies.
• Collaborate cross-functionally to ensure lifecycle compliance.
• Provide GLP/GMP regulatory compliance training to staff.
• Investigate deviations, non-conformances, and CAPA activities.
• Keep facility ready for upcoming audits.

Skills

Attention to detail

Regulatory knowledge

Auditing

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

• 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.
• Provide GLP/GMP regulatory compliance training to laboratory and manufacturing staff.
• Investigate and support resolution of deviations, non-conformances, and CAPA activities.
• Maintain readiness of the facility for upcoming audits.

• 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