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Quality Assurance Specialist

Atrium

South Brunswick, NJ

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JOB DETAILS
SALARY
$31–$35 Per Hour
SKILLS
Analysis Skills, Auditing, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Detail Oriented, Documentation, Documentation Review, Drug Manufacturing, Environmental Sciences, Genetics, Insurance Regulations, Internal Audit, Interviewing Skills, Maintain Compliance, Manufacturing, Manufacturing Audit, Manufacturing/Industrial Processes, Organizational Skills, Patient Safety, Product Safety, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Root Cause Analysis, Safety Standards, Standard Operating Procedures (SOP), Supply Chain, Support Documentation, Team Player, Vendor/Supplier Evaluation
LOCATION
South Brunswick, NJ
POSTED
1 day ago
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.

Salary/Hourly Rate:
$31/hr - $35/hr

Position Overview:
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.

Responsibilities of the Quality Assurance Specialist:
  • 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.
Required Experience/Skills for the Quality Assurance Specialist:
  • 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.
Preferred Experience/Skills for the Quality Assurance Specialist:
  • 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.
Education Requirements:
  • Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, Quality Assurance, Regulatory Affairs, or a related scientific discipline.
Benefits:
  • Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).
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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: 399402

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