Search Jobs

Your NEXT GREAT OPPORTUNITY is within reach!

Quality Assurance Auditor

Schaumbrug, Illinois

Post Date: 09/14/2017 Job ID: 1610 Job Category: Clinical: Quality

Basic Function:

To conduct audits of new and existing suppliers and vendors in support the new and commercialized products, as well as internal audits. Responsible for scheduling, performing, and reporting the audit results as tracking follow up actions.

Education/Work Experience:
  • Bachelor Degree in sciences (i.e.: chemistry, microbiology)
  • At least 5 years of progressive challenging QA/QC experience in the pharmaceutical industry with at least 3 years of auditing experience.
  • In-depth knowledge of cGMP, cGLP, Aseptic Processing, as well as FDA trends regulations, and guidelines.
  • Capable to work independently and part of a team, able to coordinate multiple projects.
  • Must possess exceptional communication and organizational skills.
  • Ability to travel domestically and internationally (Up to 40% of the time).

Principal Accountabilities:
  • Prepares audit schedules (internal and external) and conducts QA/QC audits as directed, related to   Pharmaceutical Division’ s suppliers including contract manufacturers, active pharmaceutical ingredients, contract laboratories, as well as   Pharmaceutical Divison’ s internal audits.
  • Assist in monitoring, scheduling, conducting, and reporting of cGMP activities for Pharmaceutical Division’ s suppliers and partners.
  • Communicate the results of the audits to the manufacturing site and applicable Pharmaceutical Division personnel.
  • Assures that the suppliers/vendors/contractors meet the internal and regulatory requirements.
  • Maintain audit and correspondence records to evaluate the process trends and potential non-compliance to the quality requirements.
  • Coordinate and perform compliance projects as required by the management. Projects may include product reviews, equipment and process qualifications, change control, etc.
  • Review and assess the audit responses against the current industry standards and guidelines to ensure that sufficient controls are in place and meet   Pharmaceutical Division’ s Quality standards and requirements. Follow up on the implementation of the corrective actions associated with the audit observations until completed.
  • Provides quality evaluations of suppliers and contractors to reduce the risk of data or site being unacceptable to Pharmaceutical Division quality standards and FDA requirements.
  • Ensures that the audit budgets are not exceeded by advance scheduling and ensuring that multiple audits are performed in the same geographical area in order to minimize expenses.
  • Serve as QA representative on multi- site multi-function project teams, as needed.
  • Support and participate in project management meetings as necessary, to ensure that the new product launches are carried out in accordance with   Pharmaceutical Division’ s quality standards.
  • Assists with batch shipment and authorization as needed.
  • Supports internal metric track and trending.
  • Supports internal APRs.
  • Acts on Vice President of Quality Assurance’ s behalf, as designated.

Specific Technical/Job-Related Skills:
  • In depth knowledge of current GMP regulations as well as FDA trends and guidelines.
  • Possesses strong organizational skills for prioritizing workload and responsibilities.
  • Strong written communication, interpersonal, and problem solving skills are required.
  • Proficient with PC-based word processors, databases and spreadsheets.   Experience in working with Finished Product manufacturers.
  • Familiarity with CMC regulatory issues a strong plus.
  • CQA a plus.


Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
Apply Online

Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: