The Manufacturing QMS Specialist is a full-time exempt role located in Chicago, IL. Under the guidance of Manufacturing Management, this position involves executing routine documentation tasks, including writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, and CAPAs. The role requires technical expertise in the upstream and downstream processes of biologics, specifically in cytokines and monoclonal antibody manufacturing.
Essential Duties & Responsibilities
Support the manufacturing team with various documentation tasks.
Review executed batch records from both upstream and downstream processes.
Manage filing of change controls, deviations, and CAPAs for the manufacturing department.
Utilize investigation tools like 5 Why or 6M for all critical/major investigations.
Participate in daily meetings with upstream and downstream teams to gather documentation requirements.
Meet weekly with Quality Assurance to ensure timely closure of Quality Management System (QMS) activities.
Author batch records, SOPs, and related forms necessary for the manufacturing process.
Request and submit all Good Manufacturing Practice (GMP) documents to Quality Assurance.
Provide support during critical campaigns, which may involve rotating shifts (wet lab work will constitute no more than 10% of the time).
Perform additional functions as required or assigned.
Adhere to all relevant policies and standards.
Position Requirements and Qualifications
Education:
A minimum of a BA or BS in Biological Sciences or a related technical field is required.
At least 5 years of experience in the biopharmaceutical industry.
Familiarity with upstream and downstream processes.
Special Skills:
Ability to collaborate effectively with team members and work independently, demonstrating strong interpersonal skills.
Excellent verbal and written communication skills, along with strong computer and organizational skills; detail-oriented.
Basic computer proficiency, including knowledge of Word and Excel.
Understanding of GMP batch manufacturing and packaging documentation, including audit and review processes.
Knowledge of cleaning verification and validation practices.
