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Quality Associate II

Quality Associate II

Planet PharmaRound Lake, IL, US
6 days ago
Job type
  • Part-time
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 23 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 35 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.
  • 35 years of experience in Quality within a medical or regulated environment.
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    Quality Associate Ii • Round Lake, IL, US