Job Information
Actalent Quality Engineer in Vandalia, Ohio
Description:
Support Quality and Manufacturing Teams by leading, managing, and completing FDA regulated technical charting and reporting for various processes.
Technical review of processing records, test results, and other operations documentation for completeness and accuracy
Write and update SOP’s, work instructions and forms
Collect and analyze data
Write non-conformance reports
Store, issue, or prepare samples, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
Assisting with corrective action preventive actions
Owning and managing process improvement projects
Management of physical inventory
Management of electronic inventory: Receives, and stores frozen tissue samples, supplies and/or finished products in conjunction with internal and external requirements.
Histology analysis
Work with Quality Assurance to ensure compliance with all federal, state and AATB regulations
Communicate process updates with team members
Skills:
Quality assurance, Quality engineering, Gmp, Ppap, Root cause analysis, Supplier quality, Quality control, Quality management, Fda, Apqp, Iso 9001, Batch record, Corrective action plans, biologics, Medical device, Audit, Quality management system
Top Skills Details:
Quality assurance,Quality engineering,Gmp,Ppap,Root cause analysis,Supplier quality,Quality control,Quality management,Fda
Additional Skills & Qualifications:
ASQ Certified Quality Engineer
Lead auditor certification
Experience researching, compiling and reviewing various types of data /info
Strong technical / report writing skills (90% of job)
Understanding of SOP, GMP, GXP and GDP
Any understanding of biologics is also a plus
Experience Level:
Entry Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.