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24 Sep 2020

Temporary QA Associate (20-14636)

Axelon Services Corporation – Posted by iris.chen@axelon.com Devens, Massachusetts, United States

Job Description

Job Description: Maintains shop floor quality presence; releases , in-process materials, and finished product; investigates and resolves deviations and complaints; conducts annual product reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.

Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.

Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
Drafts and reviews specifications and SOPs. Reviews and approves discrepancy reporting, investigations and CAPAs associated with incoming, in-process and production batch processing.

Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
May provide guidance to less experienced staff.

Requirements:

• B.S., in Chemistry, Chemical Engineering, Biochemistry or related discipline, or its equivalent is preferred.
• 5+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
• Knowledge of biotech bulk and finished product manufacturing, analytical testing is preferred.
• Knowledge of US and EU cGMP regulations and guidance.
• Strong communication skills and demonstrated ability to influence stakeholders is required.
• Knowledge of SAP, LIMS, Delta V, Maximo, Syncade are a plus
Knowledge of integrated electronic systems, including electronic batch record review is highly desirable.
Additional Job Requirements:
None

How to Apply

Please send your updated resume to iris.chen@axelon.com

Job Types: Temporary.

Job expires in 8 days.

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