QA Associate
4 weeks ago
Scope of Position
The QA Associate ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing a role in any one or more of the following functions: Quality Operations, Process Quality, Batch Release, Quality Systems, and Compliance in accordance with cGMP and related company SOPs, state, federal and local laws as applicable.
Responsibilities
- To complete quality assurance tasks as directed by the supervisor associated with the review of operations performed within the site. These may include product release, process quality, quality systems & operations, and compliance.
- To support or contribute to the preparation, review, and approval of QA-related documentation in accordance with approved SOPs.
- To perform or assist in general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, generation of technical reports, and reporting of quality metrics.
- To ensure that appropriate quality standards are applied in accordance with regulatory, pharmacopeias, and company requirements.
- To assist in quality-related activities that may include the preparation and review of GMP documentation.
- To escalate compliance issues appropriately when discovered.
- To complete assigned training in a timely fashion to ensure that both personal and department training status remains current.
- Review data to ensure conformance to product specifications and maintain quality assurance objectives to meet regulatory requirements.
- Respond to external customers
- Perform other duties as assigned.
Qualifications
- Excel in a quality-driven organization
- Understand biologics manufacturing operations
- Are organized and have attention to detail
- Can prioritize multiple assignments and changing priorities
- Can learn and utilize computerized systems for the daily performance of tasks
- Bachelors degree, or equivalent experience
- At least 3 years of Quality Assurance experience in a GMP-regulated industry, such as pharmaceutical, biologics, or medical devices, or in combination with relevant education (Bachelor's degree or higher degree preferred, or equivalent experience in the pharmaceutical industry).
- Familiarity with MS Programs such as Word, Excel, PowerPoint, Access, Project Etc.
- Knowledge of Quality Management Systems such as MasterControl.
- Knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Excellent oral and written communication
- Ability to manage multiple priorities and re-prioritize tasks as required
- Excellent problem-solving skills
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