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Job Title:  Document Control Specialist

Req ID:  21630
Job Category:  Quality
Country/Region:  US
State:  PA
City:  Sharon Hill
Zip:  19079
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

What You Will Do

We are currently looking for a Document Control Specialist, to join our team, at our Sharon Hills, PA facility. In this role, you will assist in the administration of the quality functions at the site, to assure adherence to ISO 9001, FDA 21 CFR Part 820/211, and other applicable regulatory standards. You will coordinate document control transactions, site record retention, calibration and inspection activities. In addition, you will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments, and support risk management activities where appropriate. You may also track and trend Quality data and support the site Management Review process. 

 

Additional responsibilities may include:

  • Facilitating CAPA and NCR investigations and coordinating investigation documentation.
  • Reviewing DHR’s and supporting batch record release.
  • Supporting site inspection activities and recordkeeping.
  • Supporting targeted Lean activities.
What We Offer You

This is a great opportunity to join a well-established, global company that will invest in your career growth over the long term. STERIS wouldn’t be where it is today without our incredible, talented people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal.

 

We offer a comprehensive benefits package, including:

  • Competitive pay
  • Annual merit and bonus plans
  • Business travel and all related expenses paid
  • Training and coaching
  • Medical, vision, dental and life insurance
  • 401(k) with a company match
  • Paid vacation time and paid holidays
  • Tuition assistance
  • Opportunities for advancement
What You Need To Be Successful

Associate Degree required; technically focused degree highly preferred. 
2+ years of experience in Quality, in a regulated industry (i.e. FDA/ISO). 
Must have knowledge of auditing and compliance requirements.
Clear oral and written communication skills a must.
Experience navigating a computer, along with experience with Microsoft Office programs required; database program experience is a plus.
Project leadership experience preferred.
Experience with ISO 9001 and FDA 21 CFR Part 820/211 are a huge plus.

#LI-KW1

 

STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Philadelphia

Job Segment: Document Control, Medical, CAPA, Risk Management, Database, Administrative, Healthcare, Management, Finance, Technology