Join our amazing team! We want to help you continue to succeed and grow in the life sciences industry! Our Manufacturing QMS Specialist position is a great opportunity to work with a leading Biotech company!
This is your chance to collaborate with cross-functional teams to ensure resolution of QMS action items.
We are looking for a sharp professional that possesses these top 3 skills :
- Biopharmaceutical experience
- QMS Manufacturing experience
- Upstream / downstream technique
Pay : $70k-$85k (Depending on experience)
Schedule : 1st shift M-F
Type of Job : Direct Hire
Location : Chicago, IL
At this time, Astrix cannot transfer nor sponsor a work Visa for this position.
Relocation assistance is not available for this position.
Benefits Offered :
Great Medical, Dental, Vision benefits!Prescription drug coverage!Health savings and Flexible spending accounts!Life and AD&D insurance, disability benefits, supplemental benefits, etc.Quality Management Specialist Daily Tasks : What you will do :
Support the manufacturing team with all types of documentation requirements.Review executed batch records, including those for Drug Products, Secondary Packaging, and the Upstream and Downstream departments.Manage and file change controls, deviations, and CAPAs for the manufacturing department.Track and ensure timely closure of QMS documents.Conduct investigations for critical or major issues using tools such as the 5 Whys or 6M method.Collaborate with cross-functional teams to ensure timely resolution of investigations and QMS action items.Author batch records, standard operating procedures (SOPs), and related forms or templates required for manufacturing processes.Request and submit all GMP-related documents to QA as needed.Participate in regulatory inspections and compliance activities.Provide support during critical manufacturing campaigns, including rotating shifts.Shop floor activities will comprise no more than 10% of your time.Quality Management Specialist Qualifications / Requirements :
Minimum of a BA or BS in Biological Sciences or a related technical field is required.At least 5 years of experience in biopharmaceuticals.Knowledge of regulatory compliance.
Salary : $70,000 - $85,000
