QC Associate II

Duties:

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• Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility.
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• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
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• Assist with quality risk assessments, onboarding, qualification and implementation of non-routine, new equipment validation activties.
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• Assist with implementing Client improvements and new ways of thinking toward lab processes and compliance activities.
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• Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).
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• Provide support during audits and inspections.
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• Work independently with adequate training and background of fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, Osmolalilty, Microbiology and more.
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• Review of analytical results within timeline right the first time.
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• Documents work according to cGMP and cGDP.
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• Adheres to established regulations and follows cGMP established by site.
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• Reports abnormalities and deviations in a timely and accurate manner.
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• Adheres to safety standards and identifies unsafe situations / habits and escalates approriately.
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• Maintains own training within compliance and assist other technicians and associates on operations upon completion of trainer qualification.
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• Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments
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Skills:

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• 3-5 years of industry expereince GMP experience is highly prefered
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• Demonstrates strong interpersonal and communication skills (both written and oral)
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• Strong customer focus, and an ability to interact with various departments and levels.
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• Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals
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• Able to work across functions to achieve common goals.
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• Demonstrates strong attention to detail, and an ability to focus on details of execution.
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• System familiarity that would be helpful: LIMS, Veeva & GoTrack
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Education:

Bachelors' degree in Biology or Life Sciences required.

Schedule Notes:1st Shift: Mon-Fri, 9AM-5PM

MAX BILL - ***/hr.