This position will inspect and accept/reject incoming raw packaging materials and components. Monitor operational activities for compliance with current Good Manufacturing Practices (cGMP) and FBS SOPs. Work on tasks where ability to recognize deviation from standard practice is required.
Conduct QC activities within a specified timeline to meet customer requirements.
Interact with all levels of employees and customers in a diverse and dynamic work environment.
Assist QA personnel, as necessary.
' Assists with and follows-up on non-conformances, investigations, complaints, etc.
' Assures that issues are resolved in a timely manner and corrective actions/preventive actions (CAPA) are implemented and monitors effectiveness to prevent reoccurrence.
' Supports the preparation for external and internal site audits.
' Extensively interacts with team leader to resolve quality issues.
' Performs quality review of procedures, work instructions, batch records, etc. prior to implementation
' Performs quality review of executed records
' Inspect products / materials for non-conformance
' Approve and control labels
' Review documents completed by operations personnel
' Resolve production/QC and documentation discrepancies
' Collect and trend Quality Control Data as well as maintain the QC shipping and receiving logs
Education/Training BS in a life science field of study Business
' 2-3 years of Quality Control/Quality Assurance experience
' Prior experience in biotechnology or pharmaceutical production or inspection (cGMP)
' Proficient in cGMP requirements as they relate to holding and distributing finished pharmaceuticals and biological specimens preferred
' Proficiency in application of 21CFR Parts 210, 211, and 820, as well as ICH 7 and 8
' Proficiency with computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly
' Ability to work independently and as part of a team
' Excellent written and oral communication skills
' Extremely adept in attention to detail/ follow up
' Excellent interpersonal, problem solving and planning/organization skills
' Environment Office and warehouse, exposure to dry ice, liquid nitrogen, hazardous, and infections agents including need to work in a -20 degree C walk-in freezer for periods of time.
' Physical requirements must be able to stand for up to 8 hours per day. Ability to lift up to 50 lbs.
Non-negotiable hiring criteria:
' Prior cGMP experience
' Strong attention to detail
' Problem solving skills
' Ability to work independently
Nesco Resource 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.
Product Quality Assurance
Corrective And Preventive Action (Capa)
Good Manufacturing Practices
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