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.
Manufacturing QMS Documentation Specialist
Manufacturing QMS Documentation Specialist. The Manufacturing QMS Specialist will be executing routine documentation which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs etc. Responsible for supporting the manufacturing team with all kin...
Manufacturing QMS Documentation Specialist - $28.00 - $32.00 / hour
Manufacturing QMS Documentation Specialist. The Manufacturing QMS Specialist will be executing routine documentation which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs etc. Responsible for supporting the manufacturing team with all kin...
Manufacturing QMS Documentation Specialist
Manufacturing QMS Documentation Specialist. The Manufacturing QMS Specialist will be executing routine documentation which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs etc. Responsible for supporting the manufacturing team with all kin...
Manufacturing QMS Documentation Specialist
Manufacturing QMS Documentation Specialist. The Manufacturing QMS Specialist will be executing routine documentation which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs etc. Responsible for supporting the manufacturing team with all kin...
Global Banking & Markets - JBA Classic - Administrative Assistant
Global Banking & Markets - JBA Classic - Administrative Assistant. Our Junior Banker Assistants are responsible for providing extensive administrative support to 25+ Junior Bankers at Analyst, Associate up to Junior VP level. A global financial company is seeking a Junior Banker Assistant. This role...
Senior Specialist, Quality Assurance
Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates ...
Clinical Support Specialist-HYBRID
Implements statewide policies and operational procedures for Clinical staffing process; monitors and reviews program standards to ensure compliance with Department and Children Family Services (DCFS) policies and procedures; identifies performance problems and develops resolutions; provides consulta...
Indexing Quality Assurance Specialist
To perform the duties of the Indexing Quality Assurance Specialist, the Indexing Quality Assurance Specialist must have knowledge of real estate documents and legal descriptions of real property. Reporting directly to the Assistant Manager of E-Recordings Operations and Indexing Exemption Processing...
Senior Supplier Quality Specialist
Senior Supplier Quality Specialist. High-quality people and high-quality products. Thats what youll find when you join Uline as a Senior Supplier Quality Specialist. Establish and implement product quality standards and review processes across North America to ensure all products adhere to Ulines qu...
Ft Hr Administrative Assistant (work From Home)
Competitive pay / Benefits (Medical-Dental-Vision-Disability-401k) / Generous time off - As an HR Administrative Assistant you'll: Answer and direct departmental emails and phone calls; Process required paperwork for employee transfers, changes in job classification, salary increases, and other rela...