Manufacturing QMS Specialist III
Found in: Talent US C2 - 2 weeks ago
The Manufacturing QMS Specialist III, is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC. This position is located in Chicago, IL. Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will be executing routine documentation work which includes writing and reviewing deviations, change controls, investigation reports, executed batch records, SOPs, CAPAs etc. This position requires process understanding of drug product manufacturing and packaging, upstream, downstream process of biologics.
Essential Duties & Responsibilities
- Will be responsible for supporting the manufacturing team with all kinds of documentation.
- Documentation includes reviewing executed batch records (Drug Product, Secondary Packaging, Upstream department and Downstream batch record).
- Will be responsible for filing change controls, Deviation, and CAPA for manufacturing department.
- Will be responsible for tracking and closure of QMS documents.
- For all critical / major investigation, will have to use investigation tools like 5Why or 6M method.
- Coordinate with cross functional team for timely closure of investigations and QMS action items.
- 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.
- Participate in Regulatory inspection and compliance activities.
- During critical campaign, will support manufacturing process (rotating shifts)
Shop floor work will not be more than % of your time.
- Performs other functions as required or assigned.
- Complies with all company policies and standards.
Education:
- A Minimum BA or BS in Biological Sciences or related technical field is required.
- Knowledge in Regulatory Compliance
Special Skills:
- 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.
Work Environment & Physical Demands:
- Noise: No extraordinary noise levels.
- Standing/Lifting: No extraordinary requirements.
- Visual: No extraordinary requirements.
- Stress: High-paced demanding environment to meet ambitious project goals.
- Travel: None
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
Supervisory Responsibility, if any : No
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
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