Manufacturing QMS Documentation Specialist - $28.00 - $32.00 / hour

Title : Manufacturing QMS Documentation Specialist

Location : Chicago, IL

Hire Type : Contract-to-Hire (W2, with full employee benefits)

Pay Range : $30.00 - $32.00 / hour

Overview :

Sterling has helped build careers for thousands of professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.

As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.

Job Summary :

The Manufacturing QMS Specialist will be executing routine documentation which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs etc.

This position requires technical expertise in the upstream and downstream process of biologics (e.g., Cytokines, monoclonal antibodies manufacturing, etc.).

Job Duties :

• Responsible for supporting the manufacturing team with all kinds of documentation.
• Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record).
• Will be responsible for filing change controls, Deviation, and CAPA for manufacturing department.
• For all critical / major investigation, will have to use investigation tools like 5Why or 6M method.
• Attend daily meetings with both upstream and downstream process to get all the documentation requirements for the day.
• Will meet weekly with QA to avoid any delay in the QMS closure.
• Will author batch records, SOPs and associated forms / formats required for the manufacturing process.
• Will be responsible for requesting / submitting all GMP documents to QA.
• During critical campaigns, this person will support the wet lab and manufacturing process.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Qualifications :

Bachelor's Degree in Biological Sciences or a related technical field is required.

Minimum 5 years of experience in Biopharmaceuticals.

Knowledge of Upstream and Downstream Processes.

• Ability to work with other team members and independently - good interpersonal skills.
• Good communication skills : verbal and written, good computer and organization skills, detail oriented.
• Basic computer skills, including knowledge of Word, Excel and spread sheet
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Knowledgeable in cleaning verification / validation.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identify, national origin, disability, protected veteran status, or genetic information.