Associate QC Manager

About the role

West is looking for an Associate QC Manager for an onsite position, with the team member present for all scheduled workdays; no relocation assistance is provided. The role is accountable for the day-to-day performance of safety, quality, delivery, cost and productivity, and for leading teams of QC Technicians and Team Leads in executing QC processes.

Key responsibilities

• Manage team schedules and resources to meet daily inspection targets and support Work In Progress controls
• Ensure proper product release and rework, and lead product characteristic trend monitoring with escalation and follow-up
• Resolve escalated operational issues, define goals, coach and counsel QC employees, and manage onboarding, training and requalification
• Review SOI revisions, close deviation and out-of-spec reports with root cause analysis and CAPA, and manage batch dispositions
• Update Tier 1 to Tier 3 records in the LDMS system and act as QC representative at Tier 2 and Tier 2.5, facilitating Tier 1 shift start-up
• Support site initiatives such as safety programs, lean initiatives and training, and handle non-routine requests such as validations, investigations and non-conformance reports

Required profile

• Bachelor's degree in a technical or engineering field
• Preferably 8 years in QA/QC, including at least 5 years managing a QC team
• Exposure to medical device, pharmaceutical or related manufacturing preferred
• Rotating shifts, overtime and on-call duty; occasional work on different shift patterns
• Minimum 20/30 vision at near and/or far with at least one eye, no colour deficiency

Required skills

• Knowledge of standard operating procedures and the company's safety and quality policies
• Preferred: SAP, cGMP, basic Lean and/or ISO experience
• Ability to support Lean Sigma programmes and risk assessment control practices