Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)

Role Summary

Sr. Associate Plant QA Night Shift

Responsibilities

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems.
• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
• Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
• Review and approve batch production records and other GMP documentation in support of daily operations, including data entries before production activities take place.
• Perform finished product checks during (commercial) production runs.
• Compile and review batch records for lots assembled, packaged and labeled at AOH in preparation for batch disposition.
• Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms.
• Review and approve Deviation, CAPA, and Change Control records.
• Participate in self-led inspections and provide support during internal/external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives.
• Adhere to safety rules and maintain a safe work environment for yourself and others by supporting EHSS corporate and site goals.

Qualifications

• Basic Qualifications:
  • High school/GED + 4 years of Quality and/or GMP Manufacturing experience
  • OR Associate’s + 2 years of Quality and/or GMP Manufacturing experience
  • OR Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
  • OR Master’s
• Preferred Qualifications:
  • Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
  • Experience in and knowledge of GMP/GCP operations or similarly regulated industry
  • Affinity with digital innovation, data sciences and Quality engineering
  • Experience with raw material receipt, inspection & sampling
  • Highly effective verbal and written communication skills, strong interpersonal skills
  • Great attention to detail and high degree of accuracy in task execution and GMP documentation
  • Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
  • Strong organizational skills, including ability to follow assignments through to completion
  • Direct experience with Enterprise Resource Management software (SAP), TrackWise, CDOCS etc.

Skills

• Quality assurance
• GMP/GCP operations
• Documentation control
• CAPA, Deviation, Change Control management
• Regulatory inspections support
• Lean and Operational Excellence

Education

• Not specified beyond qualifications listed above