**Manufacturing QMS Specialist** Manufacturing Chicago, IL, US Pay Rate Low: 70000 | Pay Rate High: 85000 + Added - 17/01/2025 Apply for Job _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: 1. Biopharmaceutical experience 2. QMS Manufacturing experience 3. Upstream/downstream technique **Pay:** $70k-$85k (Depending on experience) **Schedule:** 1 st 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. **Manufacturing QMS 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. **Manufacturing QMS 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. **_We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_** INDBH \#LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.