Associate, QAIP

Job Description

Job Summary

Responsible to ensure quality products (including compounding, and sterile and non-sterile filling and packaging) are manufactured and packaged according to Good Manufacturing Practices (GMP) and established Standard Operating Procedures (SOP) through quality presence on the production floor.  This includes specific responsibility to provide direct quality oversight and verification of sterile manufacturing, with the ability to coach and mentor production and quality to ensure continuous knowledge transfer and accurate execution of aseptic practices.

Job Responsibilities

Production & Sterile Manufacturing Oversight

• Provide continuous quality oversight on the production floor to support real-time, compliant decision-making.
• Serve as QA Subject Matter Expert for aseptic practices during sterile manufacturing, including verification of line setup, critical interventions, cleaning, and environmental controls.
• Perform routine inspections of production and packaging areas to ensure adherence to established standards and procedures.

Quality Systems & Investigations

• Initiate, lead, and support deviation investigations, non-conformances, and CAPA implementation to ensure timely, compliant resolution and prevention of recurrence.
• Generate deviations when observing departures from approved procedures or acceptance criteria.
• Review and approve minor non-conformances and ensure compliant document corrections.

Documentation & Batch Record Review

• Review and approve production and batch documentation, with a primary focus on sterile manufacturing records and data integrity.
• Perform real-time and retrospective online batch record reviews.
• Review audit trails and ensure accurate batch receipt, review, and release within QA supply systems.

Sampling, Validation & Monitoring

• Coordinate and perform cleaning validation and verification sampling, including documentation and equipment release activities.
• Perform in-process sampling, inspections, and review of physical testing results, reporting outcomes in SAP and LIMS.
• Execute scheduled continuous monitoring and improvement plan activities.

Training, Collaboration & Support

• Coach and mentor production and quality personnel on aseptic practices and GMP expectations.
• Assist with onboarding and training of new team members and act as delegate for the Supervisor, QAIP as required.
• Support customer complaint investigations and corrective maintenance impact assessments.
• Collaborate cross-functionally, influencing without authority to achieve quality and operational objectives.

Compliance & Professional Conduct

• Maintain compliance with GMP, safety, environmental, ethics, and corporate quality policies.
• Demonstrate organizational values of Collaboration, Courage, Perseverance, and Passion.
• Perform additional related duties as assigned.

Job Requirements

Education

• Bachelor of Science degree or equivalent in a related discipline or College Diploma in a related discipline

Knowledge, Skills and Abilities

• Strong working knowledge of GMP, cGMP, HPFBI and FDA requirements
• Strong working knowledge of compliant aseptic practices, contamination control, and environmental monitoring
• Excellent written and verbal communication skills in English
• Demonstrated experience in leading and motivating personnel by influencing without authority within a fast paced environment towards a common goal(s)
• Strong computer skills, good organizational, inter-personal and communication skills
• Flexibility to work in day and night 12 hours continental shifts in rotation (7 Days & 7 Nights Per month)

          Day Shift: 2 Days Work, 2 Days Off, 3 Days Work, 2 Days Off, 2 Days Work, 3 Days Off

          Night Shift: 2 Days Work, 2 Days Off, 3 Days Work, 2 Days Off, 2 Days Work, 3 Days Off

 Experience

• 5+ years of experience in the pharmaceutical industry
• 3+ years of experience in a sterile manufacturing pharmaceutical environment, within quality or production.