DISYS – Digital Intelligence Systems Hiring for QA Deviation Reviewer at Summit, NJ Full Time

Title: QA Deviation Reviewer

Location: Summit, NJ

Duration: 06 Months (With possibility of extension)

50% onsite 50% remote

Monday-Friday 8:00 am-4:00 pm

Knowledge, Skills, and Abilities:

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
• Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
• Must provide guidance to other employees in the interpretation of technical/scientific issues
• across a majority of the job function and manage development of technical or scientific
• initiatives and activities by interdisciplinary teams.
• Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.
• Must possess an independent mindset and tenacity.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
• Confident in making decisions for minor issues.
• Routinely recognizes Quality issues and solves problems.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Ability to interpret results and situations and articulate recommendations for resolution.
• Is recognized Subject Matter Expert within the group.
• Capable of providing input within the department and cross functional teams.
• Provides guidance to other employees in interpretation of complex data.
• Able to write and review reports with clarity and brevity.
• Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
• Able to effectively multi-task and execute project management skills.
• Knowledge of US and global cGMP requirements.

Job Types: Full-time, Contract

Pay: $75.00 – $80.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Summit, NJ 07901: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Required)

Work Location: One location