Quality Assurance Associate

About Atrium:
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Client Overview:
Our client is a global pharmaceutical organization partnering with third‑party manufacturers to deliver high‑quality therapies. The team is committed to compliance, product quality, and continuous improvement. They are now looking for a Quality Assurance Associate.

Salary/Hourly Rate:
$25/hr - $30/hr

Position Overview:
The Quality Assurance Associate for medical device and pharmaceutical products will review batch records for solid oral and injectable products, support batch release, coordinate with CMOs/CPOs, and assist with market complaint activities. This role ensures compliance with GMP standards and contributes to the continuous improvement of quality systems.

Responsibilities of the Quality Assurance Associate:

• Review Batch Manufacturing & Packaging Records for compliance.
• Support batch release by verifying documentation accuracy and GMP adherence.
• Communicate with CMOs/CPOs to resolve documentation issues.
• Support complaint investigations and CAPA follow‑up.
• Initiate retain and stability sample memos.
• Review stability data and track study completion.
• Participate in quality system activities for third‑party products.
• Maintain strong data integrity practices.
• Assist with other QA tasks as needed.

Required Experience/Skills for the Quality Assurance Associate:

• 2-3 years QA experience in pharma/biotech.
• Sterile, solid dosage, or injectable manufacturing experience.
• Strong batch record review skills (injectable experience preferred).
• Familiarity with GMP/21 CFR 210-211.
• Experience communicating with CMOs/CPOs.
• Strong documentation and data integrity skills.
• Excellent communication and teamwork abilities.

Preferred Experience/Skills for the Quality Assurance Associate:

• Knowledge of combination products.
• Experience with SAP or similar ERP systems.

Education Requirements:

• Associate's or Bachelor's degree in a scientific field, or equivalent experience.

Benefits:

• Medical, Vision, Dental options.
• 401K, Life Insurance, Short & Long Term Disability.
• PTO, Reimbursement, and more.

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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

Position ID: 160118