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Manufacturing Specialist - Biotech

Duties:
•- Review all minor deviations and provide coaching to all other employees authoring deviations
•- Provide coaching to employees leading deviation triage and classification activities
•- Manage the overall deviation workload among specialists, meeting target due dates
•- Create, own, and drive CAPA's and Change Controls through completion.
•- As needed, lead the authoring of manufacturing investigations, including root cause analysis and product impact assessment
•- Lead most investigation discussions during regulatory inspections
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•- Change control management and implementation
•- Create Purchase Requisitions as required to support Manufacturing and other Operations' activities

Skills:
•- Must be able to use complex electronic systems such as SAP and Trackwise
•- Must have the capacity to develop in-depth knowledge of manufacturing operations and various quality systems
•- Exceptional technical problem solving skills and the ability to teach and coach others in this area
•- Exceptional knowledgeable of current Good Manufacturing Practices (GMPs) and regulatory requirements
•- Must possess exceptional verbal and written communication skills
•- Recommended 5+ years' experience in a GMP biotech/pharmaceutical manufacturing environment or have a significant level of transferrable work experience to ensure the immediate support of the manufacturing team

Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Company
Nesco Resource
Posted
10/06/2021
Type
Full time
Salary Range
$27,000.00 - 45,000.00
per Year
Salary range estimated by
Location
Bogart, GA 30622, US