MFG Associate II
Location:
Bothell , Washington
Posted:
February 08, 2017
Reference:
1705600399
We seeking qualfied MFG Asssociate II to work in the city of Bothell, Washington.Key responsibilities for this great role will be:


Revise site MFG SOPs
Review executed production records and associated data
Work within site quality management systems
Work within site asset management systems

Provide support in quality system programs such as Deviation, CAPA, Change Management
Participate in maintaining facility/test laboratory GMP compliance
Conduct investigations into MFG deviations
Perform root cause analysis on MFG deviations
Serve as primary author of deviation reports

Assist in ensuring regulatory inspection readiness
Review records and assist in record closure for Lot Disposition process
Serve as liaison between multiple groups including manufacturing, quality, and process development









Minimum job reqjuirements:

B.S. in scientific discipline preferred
Experience in conducting investigations and root cause analysis

Three+ years of relevant experience in a pharmaceutical or FDA/GMP environment
Experience with GMP Compliance in clinical/commercial manufacturing
Experience with quality management software (Mastercontrol, Trackwise, etc.) preferred
Experience with asset management software (Blue Mountain, Maximo, etc) preferred

Strong knowledge of FDA and EU regulations for APIs and Drug Products
Ability to understand and apply GMP regulations as they relate to manufacturing
Technical writing skills

Computer literacy required
Demonstrated ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated
Strong interpersonal, written and oral communication skills

Strong problem solving skills










If interested, please respond by the COB August 23rd, 2016 since managers are actively interviewing candidates for this great opportunity!




A little about us:
We partner with people to improve skills, teams and lives every day, and we help them achieve more than they ever thought possible.

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