Mfg Batch Record Reviewer - Positive Work Culture

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).