Associate Compliance Specialist, Quality Event Management

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Summarized Purpose: Supports and implements quality and compliance processes. Facilitates the tracking and reporting of activities and tasks. Maintains tools and materials, and offers expertise to advance the vision of the department.

Job Requirements:

• Researches and addresses issues using problem solving methodology, documents in accordance with ALCOA principals and metric compliance related to quality activities.
• Knowledgeable of quality processes and ensures appropriate execution and completion.
• Participate in small to medium-scale process improvement initiatives.
• Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).
• Develops support materials, presentations, and/or tools to support department's remit and strategies.
  
  

Job Complexity: Works on problems of diverse scope with subject matter input, appropriate management of data, requires good problem solving skills

Job Knowledge: Experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.

Supervision Received: Normally receives detailed instructions on all work.

Business Relationships: Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior collaborators in own area of expertise.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Effective oral and written communication skills to support communication in English
• Strong prioritization and time-management skills
• Knowledge of the clinical trial process
• Knowledge and understanding of ICH GCP and other relevant regulations and guidelines
• Shown problem solving skills, including root cause analysis, corrective/preventive action(s) and effectiveness checks
• Strong attention to detail
• Strong computer skills; ability to learn and become proficient with appropriate software
• Demonstrated ability to prioritize tasks for efficient workload management
• Shown flexibility and adaptability
• Effective judgment, decision making, issue and risk management skills
• Strong creative and critical thinking skills
  
  

Management Role: No management responsibility

Working Conditions and Environment:

• Work is performed from a remote home based office environment with exposure to electrical office equipment.
  
  

Physical Requirements:

• Ability to work in an upright and/or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate so others will understand; ability to listen to and understand information presented through spoken words and sentences.
• Frequent cross-functional interaction to acquire related information.
• Works independently with moderate guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of concentration.
• Performs broad selection of variable tasks as determined by demands and changing conditions with little predictability as to the occurrence.
• Ability to perform under stress.
• Ability to multitask.
• Regular and consistent attendance.