Analyze Raw material, In-process, Finished Products and stability samples assuring compliance with standard operating procedures, Compendia sources, Test methods and Protocols.
With minimal guidance and supervision, conducts Routine and non-routine activities. Performs analytical testing of raw materials, in-process control materials, stability samples, and finished product (Commercial, Clinical and Registration Batches) using different analytical techniques.
Diligently follow written laboratory protocols, guidelines, procedures and methods.
Expected to utilize established scientific techniques to compile and analyze data.
Participate in laboratory investigations.
Ensure that products are being tested strictly under cGMP conditions and disposition is taken on time as per the committed production plan for every month.
Ability to identify creative and innovative solutions of non-routine analytical tasks.
Suggests improvements of laboratory testing procedures, techniques and/or instrumentation
Performs other duties related to the position when required by laboratory management
Proficient in the use of Empower
Exposure to the basic theory and operating principles of HPLC, UV, FTIR, GC, and Malvern particle size analyzers.
Train and oversee junior chemists for routine QC activities. May be responsible for technical supervision of QC colleagues.
Perform production cleaning swab analysis on various equipment in timely manner
Perform Verification and Method Validations using various analytical techniques.
Other duties as assigned.
Ability to independently prioritize workload.
May work on multiple projects and group to ensure the desired outcome is timely.
Makes routine day-to-day decisions with in the defined job function.
Recognizes problems or compliance issues and reports to management. Proactively identifies potential problems and recommends possible solutions.
Good written and oral communication skills. Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos. Have the ability to effectively present information in a one-on-one or group situation.
Experience in chromatography (e.g. HPLC with Empower data acquisition software, GC, FTIR, UV and wet chemistry)
Knowledge of ICH, FDA, and DEA regulations.
A minimum of a BS in Chemistry degree is required
Demonstrate computer literacy with proficiency in Microsoft office software, Trackwise and Empower.
10+ years working in pharmaceutical manufacturing environment.
Solid understanding of cGMP practices and concepts.