Quality Assurance Specialist

Quality Assurance Specialist

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Quality Assurance Specialists are leading service providers to our clients providing GMP support. The individual will coordinate validation activities with the client and meet timelines.

Responsibilities:

• Provides data entry support for Quality Control teams
• Develops quality systems/procedures and provides QA guidance
• Contributes to the QA planning and risk assessment activities
• Leads or co-audits vendors, internal and external systems
• Conducts investigations of GMP related issues and creates corrective action plans
• Reviews Environmental monitoring and additional QC data
• Interprets regulatory authority regulations and guidelines to verify compliance
• Administers and maintains various Quality Management Systems, including: change management, deviation management, document control, records management, and GXP training management
• Complies with all applicable policies regarding health, safety, and environmental policies

Skill Level and Requirements:

• Ability to problem solve and troubleshoot
• Strong technical writing skills
• Proficiency in Microsoft Word, Excel, Power point, and Project
• Customer service experience in a scientific field is desired
• Energetic, results-driven with excellent organizational and prioritization skills
• Excellent written and verbal communication skills

Minimum Requirements:

• BS in a technical discipline (Engineering, chemistry, microbiology, biology)
• 0-2 years of experience in at least one of the following areas: equipment/utility qualifications, process validation, analytical method validation, or cleaning validation.
• Current driver's license and auto insurance, or other dependable means of transportation

Quality Agents offers a full suite of benefits for full-time employees including:

• Health, dental and vision insurance
• Life, AD&D and disability insurance
• Health savings account for participants in our health plan
• 401k retirement plan
• Paid vacation
• Paid sick leave

Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.