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Quality Assurance Technician

Job Description: Atilar Pharma is seeking a motivated and detail-oriented Quality Assurance Technician to support our quality systems and operations team. As a 503B outsourcing facility, maintaining the highest standards of product quality and regulatory compliance is at the core of everything we do. The Quality Assurance Technician will play an essential role in ensuring that our compounded sterile preparations meet all applicable USP, FDA, and cGMP requirements. If you are committed to quality and eager to contribute to a facility dedicated to patient safety, we encourage you to apply.

Responsibilities

· Perform quality assurance reviews of batch records, logbooks, and production documentation to ensure accuracy, completeness, and cGMP compliance.

· Support environmental monitoring programs, including sample collection, trending, and reporting in accordance with USP <797> requirements.

· Conduct in-process and finished product inspections to verify adherence to established specifications and quality standards.

· Assist in the review and management of deviations, non-conformances, and out-of-specification results, supporting root cause analysis and CAPA documentation.

· Participate in the review and revision of SOPs, work instructions, and other controlled documents.

· Support internal audits and inspection readiness activities, ensuring documentation and facility practices are audit-ready at all times.

· Assist with the management of change control processes and stability programs. · Collaborate with Operations, Pharmacy, and Validation teams to address quality issues and drive continuous improvement initiatives.

· Maintain accurate and organized quality records in compliance with regulatory requirements and data integrity standards.

Qualifications

· Bachelor of Science degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field required.

· Minimum of 3 years of quality assurance experience in a pharmaceutical, 503B outsourcing facility, sterile compounding, or cGMP-regulated environment.

· Working knowledge of cGMP regulations (21 CFR Parts 210/211), USP <797>, and FDA 503B guidance.

· Experience reviewing batch records, SOPs, and quality documentation in a regulated environment.

· Familiarity with deviation management, CAPA processes, and change control systems. · Strong attention to detail with excellent organizational and documentation skills.

· Effective written and verbal communication skills with the ability to clearly convey quality findings to cross-functional teams.

· Ability to work both independently and collaboratively in a fast-paced, compliance-driven environment.

· Commitment to patient safety, data integrity, and a culture of continuous quality improvement.

Compensation: Starting salary: $50,000 annually

If you meet the requirements and are interested in joining the Atilar Pharma team, please submit your resume and cover letter.

Job Type: Full-time

Pay: From $50,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Paid time off
  • Parental leave
  • Tuition reimbursement
  • Vision insurance

Education:

  • Bachelor's (Required)

Experience:

  • USP, FDA, and cGMP Regulations: 3 years (Preferred)
  • Quality assurance: 3 years (Required)

Ability to Commute:

  • Houston, TX 77060 (Required)

Work Location: In person

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