GlaxoSmithKline Manufacturing Specialist (Investigative) in Rockville, Maryland
Manufacturing Specialist (Investigative)
Open date:Mar 13, 2018 3:00 PM
Experience required:2 years
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Your Responsibilities:Reporting into the Specialist team, the role will assist with execution of the production schedule by
troubleshooting and remediating operational and process issues, executing root cause investigations,
owning/authoring deviations and other quality report types, and revising GMP documents such as SOPs and
Manufacturing batch records.
Key Responsibilities (10 bullet points maximum)
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
. Initiates Quality Records and conducts deviation investigations.
. Leads or assists in investigations including root cause analysis and assesses product impact using
input from various departments
. Develops, executes and oversees CAPAs
. Supports Tech transfer and process monitoring support as needed
. Works with the team to monitor critical process parameters
. Revision and management of manufacturing documents such as Batch Records and SOPs
. Leads or supports Continuous Improvement projects
. Conducts data gathering, trending, and data presentation as needed to support investigations
. Supports Manufacturing coordination efforts such as sampling, equipment modification and
maintenance, and internal inspection activities to ensure minimal interruption to routine operations
. Assists with shutdown/changeover and campaign scheduling and schedule management
. Support internal and external audits as needed
Basic qualifications:BA / BS in a scientific or technical discipline, and 2+ years of
demonstrated technical competency in biopharmaceutical manufacturing
Preferred qualifications:Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans
on time and on budget
. Excellent communication and technical writing skills
. Ability to support and/or lead system troubleshooting efforts
. Initiates change control for equipment modifications
. Assist with coordination of cleaning validation and verification activities in the manufacturing areas to
ensure minimal interruption to routine operations
. Assist in development, execution and reporting of data from biopharmaceutical technology and tech
. Participate in cross-functional teams to solve production problems
. Must be willing to work shifts
. Ability to collect, assess, and generate and depict conclusions from large quantities of production data
You may apply for this position online by selecting the Apply now button.
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