Job Information
Actalent Quality Assurance Specialist in Morton Grove, Illinois
Description:
The Quality Assurance Specialist is responsible for the execution of day-to-day quality activities related to the company-wide quality management system (QMS) with a focus on Production and Quality documentation.
Essential responsibilities:
A. Establishes, develops, and supports quality programs
B. Represents in customer audits and FDA inspections
C. Follow-up on corrective actions encompassed in CAPA program
D. Approve deviations and other investigation reports
E. Auditing of departments
F. Review and approve equipment qualifications and process and cleaning validations
G. Review of manufacturing and analytical data that relate to processes manufactured under GMP conditions
H. Release of Active Pharmaceutical Ingredients for distribution
I. Writing, assembling, and filing annual product reviews reports.
J. Review Engineering work orders.
K. Review stability and reference qualification protocols and summary documents
L. Approve specifications, methods, and SOPs
M. Audit external suppliers and vendors
Skills:
Quality assurance, Gmp, Batch record, Label Inspection, root cause analysis, Raw material release data, Science, Batch record review, Document control, Audits, CAPA, Deviations, HPLC, lab testing, Lab documentation, Biology, Chemistry, Inspection, iso standards
Top Skills Details:
Quality assurance,Gmp,Batch record,Label Inspection,root cause analysis,Raw material release data,Science,Batch record review,Document control,Audits,CAPA,Deviations
Additional Skills & Qualifications:
• 5-10 years’ experience
• GMP, FDA
• Needs Pharma experience
• Skills
o Investigations
o CAPA
o OOS
o Change control
o Inspections/audits
o Management/conflict resolution
• Systems/software
o UniPoint is ideal, this is the system they use
o Trackwise
o Openlab
o Empower
o Chromeleon
• Personality
o Outgoing
o Go getter
o Independent worker
Knowledge and Skills
A. Strong knowledge of GMPs for APls.
B. Working knowledge and understanding of QC Operating systems: Chromeleon ideal – Like Empower and OpenLab
C. Working knowledge of a QMS system _ UniPoint Ideal – like TrackWise and Master Control
D. Practical knowledge of FDA inspections.
E. Flexible to take on other assignments as required.
• Proficient with Chromeleon is a plus.
• Experience with electronic document management systems.
• Competencies: attention to detail, organizational skills, teamwork, collaboration, verbal and written communication skills, project and time management, and independent judgment
-ISO standards are also a plus
Education and experience
A. Bachelors Degree in Sciences area, or equivalent combination of education and experience.
B. 5 years of experience in a regulated GMP environment. (Med Device, Pharmaceutical - API, or Finished dose form)
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.