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Quality Assurance Specialist

Your Role:

  • Supports the investigation of customer complaints through batch record review, trend analysis and CAPA evaluation
  • Support the Supplier Quality Management (SQM) system through supplier evaluation (i.e. survey analysis, supplier quality audits, supplier risk assessment).
  • Support Internal Quality Audit (IQA) program through completion of internal audits according to audit schedule.
  • Manufacturing support through statistical analysis, CAPA investigations, complaint investigations, and validation support.
  • Oversee the CAPA system to ensure effective corrective and preventive actions are implemented to prevent reoccurrence.
  • Oversee the change control system to ensure effective execution of change control activities
  • Execute documentation revisions and approvals within the electronic documentation database
  • Assist validation by reviewing protocols, execution of protocols, reviewing / writing of final reports
  • Provides monthly quality indicators and improves results.
  • Apply the requirements fixed in the Quality Assurance and ensure that the procedures are followed. Apply the safety requirements. Be involved in customer audits for systems engineering and manufacturing plant, keep the general specifications up to date.
  • Ensures that the ISO, cGMP, and USDA guidelines and corporate policies are followed. Respects the factory safety rules.

 

Who You Are:

 

Basic Qualifications:

  • Bachelors Degree in a Quality or Science discipline preferred (i.e. Chemistry, Biology, or Medical Technology).
  • 3+ years progressive responsibility and experience in a drug manufacturing, medical device, or biologics industry in Quality Assurance position.
  • Demonstrated experience in development and management of CAPA, Change Control, and document control systems.
  • Demonstrated experience with internal and external audit processes.
  • Demonstrated expertise in cGMPs, FDA regulations, and SOP development.
  • Demonstrated basic computer skills and a working knowledge of basic computer software (Microsoft Office, MiniTab).
  • Six Sigma training/certification a plus.
  • Demonstrated verbal and written communication skills including the ability to conduct verbal presentations.
  • Demonstrated success working a team environment.
  • Ability to travel by car and/or plane, typically up to 25%. Additional travel may be required based on business need.

 

Preferred Qualifications:

  • Certified Quality Auditor (CQA)
  • Project management experience
  • Six Sigma training/certification.
Job Requisition ID:  185551
Location:  Kankakee
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Kankakee
Nearest Secondary Market: Bradley

Job Segment: Medical, CAPA, Quality Assurance, QA, Quality, Healthcare, Management, Technology

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