QA Specialist I - Intern (Multiple Positions Available)
Location: Frederick, MD
We are currently seeking rising undergraduate juniors or seniors working towards a degree in Engineering or Life Sciences for a 10-12 week internship during the summer of 2023.
Objectives/Goals of the Position:
This position objective/goal will be focused around development or improving Data Trending processes/visualization for the data that is available within the Quality Management Systems (specifically EQV, but also other systems such as FileTrail inventory system).
This effort would add agility to the customer service, trend analysis, and overall performance for the site for forums such as Tier, QMR, QuaSAR, CoP, continuous improvement projects, etc. The position also will look to assist other quality teams such as QA Validation to help improve data visualization tools for consolidating and analyzing Risk Assessment content. Improve tools for QA-ATS batch review trending and create trending/visualization tools for QA observation logs.
Primary Duties:
A. Performs selected quality assurance activities, dependent upon assigned area, including the following:
• Reads, understands, and follows SOP’s and complies with cGMP’s
• Writes new standard operating procedures or revises existing documentation utilizing document management systems.
•Electronic system usage with tools such as Enterprise Quality Vault (EQV), FileTrail SAP and PAS-X (electronic batch records).
B. Understands basic scientific principles and current Good Manufacturing Practices (cGMP).
• Basic knowledge of functional procedures and routine activities within core area.
• Applies knowledge to recurring, standardized tasks.
• Uses basic analytical skills to develop solutions to task-related problems.
• Escalates/seeks support for more complex problems as appropriate.
C. Works under regular and routine supervision following standard procedures.
• Receives detailed instructions for new assignments.
• Priorities are set by others.
• Work is reviewed for accuracy and completeness.
• Contributes to department goals through quality and efficiency of standard work.
• Contacts are primarily with department peers and supervisor and cross-functionally with peers/supervisors from other internal departments.
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
Requirements:
- Rising undergraduate juniors or seniors working towards a degree in Engineering or Life Sciences.
- Meticulous approach to work (attention to detail).
- Creative mindset and ability to approach a problem creatively (problem-solving).
- Good communication skills, both written and verbal.
- Proficient with computers and associated software for the purposes of managing and presenting data in a variety of ways.
- Ability to use logic and reasoning to identify strengths and weaknesses of electronic systems.
- Time management skills.
- Ability to work as part of a team.
- Data analytics / programing a plus (desirable but not mandatory)
- Minimum grade point average of 3.0