Quality Systems Specialist I

Posted 09 Dec 2022

Kankakee, Illinois - United States

Req Id 259202

Work Your Magic with us! 

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

 


Your Role:

 

The Quality Systems Specialist executes, maintains, and continually evaluates Quality Assurance methods and processes. With a focus in one QA functionality, this role also supports the other QA functions of the site. These include Change Control, Deviation and CAPA, Supplier Quality, Auditing, Document Control, Batch Record reviews, and Training.

 

  • Executes, maintains, and continually evaluates quality assurance and/or control methods and systems
  • Utilizes standards and procedures to provide quality guidance and methods
  • 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
  • Travel by car and/or plane, typically up to 5%. Additional travel may be required based on business need

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in a scientific field (e.g., Biology, Chemistry, Engineering, etc.) or Quality Management
  • 5+ years progressive experience in a drug manufacturing, medical device, or biologics industry in a Quality Assurance position

 

Preferred Qualifications:

  • Project management experience
  • 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 OfficeMiniTab)
  • Six Sigma training/certification
  • Demonstrated verbal and written communication skills including the ability to conduct verbal presentations
  • Demonstrated success working a team environment
  • Certified Quality Auditor (CQA)

 


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance

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.

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.


Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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