The Senior Quality Manager will be responsible for daily oversight of Quality Assurance functions, such as: QA inspections, Document Control, and Change.
location: Allentown, Pennsylvania
job type: Permanent
salary: $130,000 - 150,000 per year
work hours: 9 to 5
responsibilities: Duties and Responsibilities:
- Oversees compliance to internal procedures, policies and standards, as well as all relevant State, Federal and International regulations.
- Provides technical expertise in the manufacturing, packaging, and testing activities associated with the manufacturing of solid dose and liquid drug products.
- Revises departmental procedures (SOPs) as necessary to ensure compliance to regulatory standards and company policy.
- Maintains a working knowledge of government and industry quality assurance codes and standards.
- Assists in the training of employees on GMP.
- Other duties as assigned
qualifications: Education and/or Experience:
- Bachelor of Science degree (science or engineering preferred) or Advanced degree in Business or Engineering
- Minimum of 10 years of experience in managing and improving Quality systems
- Experience hosting or assisting during customer or regulator agency inspections.
- Extensive audit experience for API, excipient, and components used in the pharmaceutical industry. Auditor certification, for example ASQ Certified Quality Auditor, preferred.
- Detail oriented with well-developed organizational skills
- Must be "flexible" and capable of adapting to changes that occur due to changing business needs
- Able to effectively verbally communicate to multiple level personnel and departments within the company
- Must have the ability to relate to and work well with individuals and a diverse workforce in a "team" focused environment
- Able to handle multiple tasks and make quick sound decisions
- Working knowledge of business software packages, such as Word, Excel, and Access, and modern office equipment
skills: SOP, Quality Assurance, Chemistry, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.