Job Description

Quality Associate II

Location: Round Lake, IL (100% Onsite)

Contract: 1-Year

Pay Rate: $30–$33/hr. (depending on experience)

About the Role

The Quality Associate II will serve as a documentation reviewer and verifier within manufacturing documentation. This role involves working alongside quality personnel within a manufacturing environment.

• Primarily focused on reviewing 2–3 batches per day (approximately 150+ pages of documents).
• Requires extensive research and close reading for accuracy and completeness.
• Works closely with team members but will not have direct reports.
• Collaborates across departments, including manufacturing, quality, and production.

Requirements

• Education & Experience:
• BS degree with 3–5 years of experience preferred (flexible; strong lab experience from academia or workforce acceptable).
• AS degree with 3+ years of relevant experience, or
• High School diploma with 5+ years of laboratory experience.
• Experience:
• GMP or other regulated laboratory experience preferred.
• Prior experience reviewing laboratory or production documentation for accuracy and clarity.
• Strong documentation, technical writing, and attention-to-detail skills.
• Experience in roles such as Documentation Specialist , Documentation Reviewer , Manufacturing/Line Production , or Quality Associate is ideal.

Essential Duties and Responsibilities

• Lead daily departmental operations to achieve defined quality goals efficiently, accurately, and on time.
• Conduct in-depth internal assessments and evaluations by collecting and analyzing objective evidence regarding risks and their magnitude.
• Collaborate with production supervisors, quality, engineering, and other internal teams to implement necessary actions.
• Evaluate the logic, adequacy, and effectiveness of processes, systems, and requirements.
• Develop and implement corrective action plans for identified risks or non-conformances.
• Serve as a Subject Matter Expert (SME) by maintaining expertise in current regulatory requirements.
• Provide training and coaching to employees as needed.
• Write, review, analyze, and revise Standard Operating Procedures (SOPs) and submit procedural changes to meet corporate, divisional, plant, or regulatory requirements.
• Participate in external assessments and audits; evaluate and resolve product/process issues using technical and analytical skills.
• Support the timely closure of audit observations and findings.
• Oversee audits of various reports (e.g., Protocols, Qualifications, Regulatory Submissions).
• Contribute to QA/QC multi-site projects as a contributor, coordinator, or lead.
• Perform other duties, tasks, or projects as assigned.

Qualifications

• Strong interpersonal skills and exceptional attention to detail.
• Team-oriented with solid problem-solving abilities.
• Excellent verbal and written communication skills.
• Ability to manage multiple projects concurrently.
• Proficient computer skills.
• Knowledge of FDA Regulations , Good Laboratory Practices (GLP) , and Good Manufacturing Practices (GMP) .
• Ability to manage people, promote teamwork, and drive decision-making when required.

Education and Experience

• BS in Business, Science, or equivalent field.
• 3–5 years of experience in Quality within a medical or regulated environment.

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