Supervise the auditing and inspection of operational activities and outputs for compliance to cGMPs,
SOPs, and other written quality standards.
- Manage the auditing and inspection of operational activities and outputs ensuring compliance with approved specifications, cGMP and Almac Clinical Services SOPs.
- Hire, train and develop personnel in order to best meet departmental and company objectives.
- Initiate and investigate planned and unplanned deviations, as required.
- Serve as key trainer in cGMP and SOP training of Almac Clinical Services personnel.
- Develop, write, review and update departmental and other company SOPs.
- Perform duties of QC Inspector as needed. Must be able to inspect material / operations within cold conditions (2-8°C).
- Perform cGMP Facility and Housekeeping audits in conjunction with Quality Assurance personnel.
- Interface with employees and HR management in order to motivate, reward, and discipline departmental personnel.
- High School Diploma or Equivalent
- Associates or Bachelor’s Degree with Science background preferred
- 3 years within manufacturing, packaging, or Quality Assurance/Quality Control environments
- 1 years supervisory management within manufacturing, packaging, or Quality Assurance/Quality Control role
- SOP training and personnel development
- Quality systems auditing
- Function and purpose of Quality Control within a manufacturing environment
- 3 years supervisory management within pharmaceutical manufacturing, packaging, or Quality Assurance/Quality Control roles
- Technical writing including SOPs and Quality Investigations
- Current Pharmaceutical Good Manufacturing Practices
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Professional development programs/ continuous learning opportunities