Quality Assurance Data Reviewer

About Atrium:

Client Overview:

Our client is seeking a detail-oriented Quality Assurance Data Reviewer to support Quality Assurance and Quality Systems activities within a cGMP pharmaceutical manufacturing environment.

Salary/Hourly Rate:

$31/hr – $35/hr

Position Overview:

The Quality Assurance Data Reviewer will support Quality Assurance and Quality Systems activities within a cGMP pharmaceutical manufacturing environment. This role is responsible for reviewing analytical and quality documentation, conducting audit trail reviews, evaluating investigations and change controls, supporting audits and inspections, and ensuring compliance with FDA regulations, ICH guidelines, and internal quality standards. The ideal candidate will possess strong knowledge of pharmaceutical quality systems, data integrity requirements, and cGMP regulations, with the ability to work collaboratively across departments to maintain the highest standards of quality and compliance.

Responsibilities of the Quality Assurance Data Reviewer:

• Support the Quality Management System for testing and release of APIs, intermediates, bulk products, and finished products in accordance with cGMP regulations and FDA/ICH guidelines.
• Review and approve laboratory instrument qualification, calibration, and analytical method validation protocols and reports.
• Evaluate Change Controls, Deviations, Laboratory Investigation Reports (LIRs), OOS, OOT, and COT events to ensure appropriate root cause determination and quality impact assessments.
• Review and assess change controls and associated risk assessments.
• Conduct periodic Audit Trail Reviews to ensure compliance with data integrity requirements.
• Participate in customer audits, regulatory inspections, and internal audit activities.
• Perform audits of contractor facilities, laboratories, warehouse operations, engineering, validation, IT systems, and manufacturing operations.
• Assist in the development, review, and approval of specifications for raw materials, packaging components, APIs, in-process materials, and finished products.
• Participate in SOP development, revisions, implementation, and training activities.
• Collaborate cross-functionally with Quality Control, Manufacturing, Validation, Engineering, Supply Chain, and other departments on quality-related activities.
• Maintain compliance with company procedures, cGMP requirements, and applicable regulatory standards.

Required Experience/Skills for the Quality Assurance Data Reviewer:

• 3–5 years of Quality Assurance, Quality Systems, Compliance, Auditing, or Data Review experience within a pharmaceutical, biotechnology, or other regulated life sciences environment.
• Experience reviewing quality documentation, investigations, deviations, change controls, and CAPA activities.

Preferred Experience/Skills for the Quality Assurance Data Reviewer:

• Experience supporting regulatory inspections and/or customer audits.
• Experience performing audit trail reviews and working with data integrity requirements.

Education Requirements:

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

Benefits:

• 401(k)
• Dental insurance
• Disability insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

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As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO