Compliance Specialist III – cGMP, Microbiological Test Methods, Validation (19-00338) – PA – Swiftwater

Working knowledge of chemical and microbiological test methods. 
Working knowledge of various validation. 
Comprehensive process understanding. 
Identify process monitoring excursions per the documented control criteria. 
Work with cross-functional teams to investigate and author process monitoring excursions. 
Back-up to lead process monitoring weekly meetings with cross functional team. 
Maintain a communication pathway with the Antigen Leadership Group on process robustness and excursions. 
Basic statistics working knowledge and basic programming (JMP, SAS). 
Proficient Technical Writer, Project Management, Root Cause Analysis.
Ability to interpret trends in data relative to process performance to drive more robust performance. 
Verbal and written communication skills. 
Adherence to commitment dates. 
Desire to work in fast-paced environment. 
Customer focused, results driven, Shop floor oriented. 
Demonstrated ability to be successful as a Leader of a diverse cross functional team.

Detailed knowledge of cGMPs.
2+ Years Industry experience
Working knowledge of chemical and microbiological test methods
Working knowledge of various validations
Comprehensive process understanding

Successful candidate has a minimum of a 4 year degree (Biology / chemistry / engineering / statistics)
Source: Job Diva – Job Listing

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