Senior QA Associate

Job Overview:

The QA Associate interprets and implements quality procedures, standards, and specifications for value streams, manages, and coordinates value stream QA activities, coordinates, and executes the review and approval of various quality programs, manages, and coordinates administrative functions within quality systems, performance management of direct reports, where applicable, and performs activities for process compliance and product release when required.

Responsibilities:

• Provide technical and operational input on the operational planning of the unit and on the prioritization of objectives.
• Provide input into the budget and resource requirements of the section.
• Request and allocate assets and resources for the fulfillment of work objectives and monitor their use, current and future states.
• Provide section staff with day-to-day direction, tasks, and support area goals and objectives.
• Manage implementation of operational changes to SOPs and processes.
• Manage and coordinate process compliance activities to ensure that GMP documents are consistent with OTIF (On-Time and In-Full) with the planning schedule.
• Perform QA release for QA / GMP documents, as needed and as qualified for.
• Create, provide, and monitor the mentoring and training of group members to support external audits. needed. 
• Create and maintain metrics/data to support decisions that will identify and mitigate risk, manage resource allocations, and identify opportunities for improvement.  
• Provide QA approval on select Quality Assurance documents, across the Quality Unit.
• 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.
• 3-5 years of Quality Assurance experience in a GMP-regulated industry, such as pharmaceutical, biologics, medical devices, dietary supplements, food, cosmetics, or in combination with relevant education.
• Strong working knowledge of pharmaceutical quality management systems (e.g., Document Control, CAPAs, Deviations, Complaints, Change Control, etc.)
• Demonstrate familiarity with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
• Demonstrates 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.
• Able 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).