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Quality Assurance Data Reviewer

Atrium

Cranbury, NJ

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JOB DETAILS
SALARY
$31–$35 Per Hour
SKILLS
Analysis Skills, Analytical Method Validation, Application Programming Interface (API), Auditing, Biology, Biotech and Pharmaceutical, Calibration, Change Control, Chemistry, Corporate Compliance, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Dental Insurance, Detail Oriented, Documentation, Drug Manufacturing, Environmental Sciences, FDA Requirements, Genetics, Health Insurance, ICH Regulations, Information Technology & Information Systems, Insurance Regulations, Internal Audit, Interviewing Skills, Investigative Reports, Laboratory Operations, Life Insurance, Maintain Compliance, Manufacturing, Manufacturing Operations, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Risk Analysis, Root Cause Analysis, Standard Operating Procedures (SOP), Supply Chain, System Test, Team Player, Validation Plan, Vision Plan, Warehousing
LOCATION
Cranbury, NJ
POSTED
2 days ago
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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About Atrium:What you do matters. Guided by our Applicant-Centric™ approach, we foster an environment of collaboration, high performance, and innovation where your talents are valued, and your achievements are celebrated. Join us and become part of an inclusive team committed to your growth and success. By applying to this job, you agree to receive calls, AI-generated calls, text messages, and/or emails from Atrium and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to opt out on any message you receive. For more details, please review our Terms of Use and Privacy Policy . 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

Position ID: 399392

About the Company

A

Atrium

Founded in 1995, Atrium is a global WBENC certified leader in Extended Workforce Management and Talent Solutions that partners with the world’s largest brands to reimagine how work gets done. Guided by our Applicant-Centric™ philosophy, we approach hiring from the perspective of the candidate. By getting to know you and listening to what truly motivates you, we build lasting relationships and find our applicants jobs they love.

COMPANY SIZE
250 to 500 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1995
WEBSITE
https://www.atriumglobal.com

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