Quality - Inspection Readiness and Support [Pharma/Med Device] St. Louis MO

  • Full-time

Company Description

CP is ranked 3rd in the NJBIZ Top 50 Companies to Work for and is listed in NJBIZ 50 Fastest Growing Companies in NJ.

CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Full Service Engineering consulting services headquartered in Sparta, New Jersey with offices in Florham Park NJ and San Diego CA. CP is committed to our clients and develops innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.

 

Job Description

  • Gather documents, print and bind documents, create presentations and storyboards and do some data entry. Data entry will likely be to Word or Excel documents or QTS/Trackwise databases. Will gather and organize documents, help with writing summaries and keep track of plan and action items to complete record files. 
  • Quality Support will also review of documents contained within the evidence binders for actions completed in response to regulatory observations and/or regulatory communications. Individual will need to be able to understand GMP documentation and provide input on documentation clarification and/or need for additions to the evidence binders.

Qualifications

  • Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy 
  • 4+ years related experience or equivalent combination of education and experience
  • 3+ years of experience in a pharmaceutical or medical device production environment
  • Auditing with GMP regulated industries required
  • Facilitation of regulatory inspections (FDA, EMA, etc.) required
  • Quality Systems in pharmaceutical industry
  • ASQ Certified Quality Auditor is preferred
  • Aseptic manufacturing is preferable

Additional Information

 

  1. All your information will be kept confidential according to EEO guidelines.
  2. Please attach WORD resume in your profile
  3. Work is on-site
  4. This is a contract assignment NOT a full-time job
  5. 1099 OR W2