MQA Associate

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Job Overview:

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:

• Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Minimum of 3+ years of Quality Assurance experience in a GMP-regulated industry, such as pharmaceutical, biologics, medical devices, or in combination with relevant education
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate understanding/ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).