Quality Associate II
Planet PharmaRound Lake, IL, USHace 3 días
Tipo de contrato
- A tiempo completo
Descripción del trabajoEducation & 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. 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. 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. BS in Business, Science, or equivalent field. 3–5 years of experience in Quality within a medical or regulated environment.
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
Essential Duties and Responsibilities
Qualifications
Education and Experience
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Quality Associate Ii • Round Lake, IL, US
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