Job Details

  • Title: QA Compliance Specialist
  • Code: RCI-09929
  • Location: North Chicago Illinois (IL) 60064
  • Posted Date: 11/19/2020
  • Duration: 6 Months
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  Job Description

Onsite once Covid 19 schedule is over This position is consider essential worker, it is full time on-site


Job Title: Quality Assurance (QA) Compliance Specialist II


General understanding of US and international regulations for quality systems and compliance

  • Batch Record Review
  • Incoming material release
  • Manufactured material release (mainly starting materials/Intermediates)
  • Material number approvals
  • Area metrics preparation
  • Bachelors’ Degree or equivalent experience is required, preferably in life sciences or engineering
  • 1-2 years’ experience in Quality Assurance or related field, prefer healthcare pharmaceutical industry or experience in quality function

Description Details

• Are you open to look at candidates willing to relocate? Local Candidates
• Years of experience/education and/or certifications required: BA/BS 1-2 years exp
• What are the top 3-5 skills requirements should this person have?
1. Attention to detail
2. Knowledge of GDP (good documentation practices)
3. Knowledge of GMP (good manufacturing practices) experience preferred
4. Good communication skills (Individual will have to approach other functional areas and obtain appropriate corrections to documents)
5. Basic to Intermediate skills with computers (Individual will be required to use an electronic inventory system and non-conformance system and must be able to quickly learn how to navigate)
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
1. Bachelor’s degree in Chemical Engineering, Chemistry or Industrial Biotechnology.
2. Experience in a manufacturing plant for Active Pharmaceutical Ingredients (API).
3. SAP experience
4. Trackwise experience
• What type of environment is this person working in?
Office and Manufacturing setting
• Work Schedule (Define days,# of hours) Mon-Fri 8 hours day , not much OT
Does this position offer the ability to work remotely on a regular basis or is it an on-site role? Onsite once Covid 19 schedule is over This position is consider essential worker, it is full time on-site
• Is the worker onshore or offshore? Onshore
• Will there be Domestic and/or International Travel? No