**Quality Assurance Analyst** 35-50/hr
About the role
We are seeking a dedicated Quality Assurance Specialist to ensure system configuration and migrated data align with GMP compliance. This role involves verifying the alignment between approved documentation and LIMS configuration, supporting data integrity assessments, and participating in various QA activities.
Responsibilities
- Verify alignment between approved documentation and LIMS configuration.
- Support data integrity assessments and documentation reviews.
- Execute QA review and approval activities related to implementation deliverables.
- Participate in User Acceptance Testing (UAT), protocol execution, and deviation resolution.
- Support SOP creation, review, and implementation activities.
- Collaborate with QC, project teams, and stakeholders during rollout activities.
- Ensure implementation activities align with regulatory expectations and company quality standards.
Requirements
- 3+ years of QA experience within a GMP-regulated environment.
- Prior participation in a LIMS implementation.
- Strong understanding of GMP documentation practices and data integrity principles.
- Experience reviewing controlled documents, specifications, and system-generated records.
- Exceptional attention to detail and organizational skills.
Qualifications
- Experience in veterinary pharmaceutical, pharmaceutical, biotechnology, or medical device industry.
- Experience supporting software validation or computerized system validation activities.
- Familiarity with ALCOA+ and FDA data integrity expectations.
- Preferred degree in a scientific discipline.
Work Environment
The Quality Assurance Specialist will work in a QA workspace and cubicle, collaborating with over five project team members and interacting with analysts, QA personnel, and leadership.
Schedule
Monday through Friday, 8:00 AM – 4:30 PM, with a flexible, hybrid work schedule available.
Pay
The pay range for this position is $35.00 – $50.00 per hour.
Benefits
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include:
- Medical, dental, and vision insurance
- Critical Illness, Accident, and Hospital insurance
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short- and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation, or Sick Leave)
Location
This is a hybrid contract position based in Bridgeton, MO.