QA Specialist

QA Specialist

The QA Specialist is responsible for ensuring compliance with all regulations and quality systems within our international distribution centers. This role involves performing time and temperature analysis for shipments within the US and LATAM distribution network, as well as managing quality events, obtaining dispositions, and overseeing product release for products at US distribution centers.

Responsibilities:

• Evaluate shipments using TTOR and MKT principles.
• Initiate quality events and liaise with manufacturing sites for dispositions and distribution centers for product release.
• Execute assigned quality projects using engineering principles, business standards, practices, procedures, and project requirements.
• Assure proper documentation of technical data generated for assigned projects and tasks consistent with applicable quality directives and procedures.
• Communicate the quality status of materials to internal customers, management, and external suppliers.
• Develop and implement departmental operational procedures to ensure regulatory compliance with FDA, GMP, ISO, and OSHA standards.
• Contribute to continuous product and process improvements in areas related to the department.
• Lead activities contributing to QMS compliance, including CAPA, change control, supplier quality, internal audits, and quality training.
• Work with other departments to ensure operational and quality goals are understood and met.
• Participate and communicate status, business issues, and significant developments in projects.
• Develop and review procedures, both internal and external.

Essential Skills:

• Effective written and oral communication skills.
• Flexibility in responding to unexpected demands.
• Ability to work independently and in a team environment.
• Competence in the selection and use of Quality Engineering tools, techniques, and processes.
• Strong computer skills, including Microsoft Office Package (Excel, Word, etc.).

Additional Skills & Qualifications:

• BS Degree in Scientific or Related Discipline.
• 0-2 years of experience, preferably in a Quality role in an FDA/GMP environment.
• Technical writing skills preferred.
• Knowledge of bioMrieux reagents and instruments preferred.

Work Environment:

The role requires working within international distribution centers, ensuring compliance with various regulatory standards. The environment promotes teamwork and collaboration, while also offering opportunities to work independently. The dress code is professional, and the working hours are typical for the industry.

Job Type & Location:

This is a Contract position based out of Hazelwood, Missouri.

Pay and Benefits:

The pay range for this position is $20.00 - $22.00/hr. 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 the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 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)

Workplace Type:

This is a fully onsite position in Hazelwood, MO.

Application Deadline:

This position is anticipated to close on Sep 23, 2025.