Job Summary
The Quality Assurance Specialist - Customer Audits is a critical role within the QA/Regulatory Affairs department. This individual is responsible for two major functions: Managing Personnel (specifically regarding CAPA, Document Review, and Technical Services) and Leading Audits. You will operate independently to schedule and execute systematic evaluations of processes and products, ensuring that Partnered Client maintains its reputation for high purity and strict regulatory compliance.
This position is a Temp-to-Permanent opportunity located in Waukegan, Illinois with standard work hours from 9:00 AM to 5:00 PM. The compensation for this role ranges from $34 to $38 per hour.
Responsibilities
Audit Management & Execution
• Lead Audits: Schedule and lead domestic and international audits, including internal audits of company facilities and external supplier audits.
• Regulatory Inspections: Co-manage regulatory inspections to ensure compliance with the GMP Audit Program.
• Compliance Verification: Verify adherence to internal guidelines, industry standards (ISO), and external regulations (FDA/EU).
Quality Systems & Process Improvement
• CAPA & Risk: Identify top compliance risks and areas of inefficiency. Document findings and drive the Corrective and Preventive Actions (CAPA) process.
• Data Analysis: Utilize quality data to identify trends and support continuous improvement initiatives.
• Documentation: Review documentation, procedures, and reports to ensure technical operations comply with applicable regulations.
Leadership & Collaboration
• Team Management: Manage personnel responsible for maintaining CAPA, Document Review, Technical Services, and Document Control.
• Training: Work with Engineering and Manufacturing teams to train staff on quality best practices and policies.
• Cross-Training: Cross-train with the Quality Assurance Customer Technical Specialist to ensure departmental continuity.
Qualifications
Education & Experience
• Required: Bachelor's degree in a related field.
• Experience: Progressive QA experience in pharmaceutical, biopharmaceutical, or medical device industries.
• Preferred: 1-2 years of specific experience in pharmaceutical quality audits (both external and internal).
Regulatory Knowledge
• Core Competencies: Strong command of Current cGMP regulations and ICH Q7 guidelines.
• Detailed Knowledge: Familiarity with FDA trends, EU regulations, IPEC, ISO 9000/9001, and 21 CFR (Parts 11, 210, 211).
Skills & Abilities
• Leadership: Ability to lead teams, manage personnel to achieve goals, and handle project management activities.
• Communication: Excellent technical writing, reporting, and verbal communication skills.
• Analytical: Strong problem-solving skills with the ability to evaluate compliance requirements against real-world situations.
Travel & Physical Requirements
• Travel: Must be able to travel domestically and internationally on occasion.
• Physical: Ability to lift 50 lbs, stand/walk/climb stairs for extended periods, and wear proper safety equipment (PPE) in a plant environment.
• Sensory: Must have good hearing and sight adequate for safety programs in a pharmaceutical manufacturing plant.
skills: Good Manufacturing Practices (GMP), Quality Assurance (QA), Regulatory Audit Preparation, International Council for Harmonization (ICH), Internal Regulatory Audits, Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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