Job Summary:
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.
Duties/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.
Required Skills/Abilities:
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
Education and Experience:
Bachelor’s 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
Physical Requirements:
• Fluent in English
Ability to travel between and within facilities to visit staff, operations, projects, etc.
,
• Ability to sit, stand, walk, and climb stairs.
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc.
when necessary).
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