Quality Assurance Specialist

Client Overview:

Our client is a leading pharmaceutical manufacturing organization dedicated to producing high-quality products in a highly regulated environment. The company is committed to quality, compliance, and continuous improvement while maintaining the highest standards of patient safety and product excellence. They are currently seeking a Quality Assurance Specialist to join their Quality team.

$31/hr - $35/hr

The Quality Assurance Specialist – Data Review & Compliance will support Quality Assurance and Quality Systems activities within a cGMP-regulated pharmaceutical manufacturing environment. This is an onsite, Monday through Friday (8:00 AM - 5:00 PM), temp-to-perm opportunity for candidates who are available to begin work immediately and reside locally.

The Quality Assurance Specialist will ensure compliance with cGMP regulations and internal quality standards by reviewing quality documentation, supporting investigations, participating in audits, and collaborating with cross-functional teams to maintain data integrity and continuous quality improvement.

• Review and approve quality documentation, analytical data, instrument qualifications, calibrations, and method validation records to ensure compliance with cGMP and regulatory requirements.
• Evaluate deviations, investigations, change controls, out-of-specification (OOS) and out-of-trend (OOT) events, and CAPA activities, including root cause analysis and quality impact assessments.
• Conduct audit trail reviews and support data integrity initiatives to maintain compliance with internal and regulatory standards.
• Participate in customer audits, regulatory inspections, internal audits, and contractor/vendor audits across manufacturing and support functions.
• Support the development, review, and approval of specifications, SOPs, quality procedures, and training documentation.
• Collaborate with Quality Control, Manufacturing, Validation, Engineering, Supply Chain, and other cross-functional teams to achieve quality and compliance objectives.

• 3-5 years of experience in Quality Assurance, Quality Systems, Compliance, Auditing, or Data Review within a pharmaceutical, biotechnology, or regulated life sciences environment.
• Experience reviewing quality documentation, investigations, deviations, change controls, and CAPA activities.
• Strong knowledge of cGMP regulations, FDA requirements, and quality systems.
• Strong analytical, organizational, and documentation review skills with exceptional attention to detail.
• Ability to work collaboratively across multiple departments in a regulated manufacturing environment.

• Experience supporting regulatory inspections and customer audits.
• Experience conducting audit trail reviews and supporting data integrity initiatives.
• Familiarity with risk assessments, validation activities, and pharmaceutical manufacturing processes.

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, Quality Assurance, Regulatory Affairs, or a related scientific discipline.

• Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).