job summary: **URGENT NEED for a Manager, Quality Assurance
. This person will provide leadership and direction to ensure the day-to-day quality systems and programs are aligned with operational execution. This person will also monitor and ensure that operations are conducted in accordance with FDA regulations and meeting cGMP and other applicable regulatory requirements.
This individual will oversee a team that monitors site operations to identify opportunities and improvements to reduce risk to GMP compliance and secure business. This individual will build strong partnerships with Operations, QC, PD, Engineering, and Maintenance staff to ensure compliance with site and FDA requirements, ensuring customer demand is met as well as cGMP's specific to the site.**
location: Allentown, Pennsylvania
job type: Permanent
salary: $100,000 - 110,000 per year
work hours: 9 to 5
- Provides technical expertise and oversight in the manufacturing, packaging, and sampling activities associated with the manufacturing of commercial pharmaceutical drug products.
- Ensures accurate and timely documentation of manufacturing and inspection activities.
- Ensures that all QA Inspection personnel are adequately trained for the functions performed.
- Develop, design and write Standard Operating Procedures (SOP) ensuring compliance with the company's policies and FDA regulations.
- Completes Quality Assurance material disposition (acceptance and rejection of material following quality systems) and assign priorities to the QA team to support these activities as well.
- Monitor Review and release of commercial batches / Process Validation batches / Exhibit and Submission batches to the Agency.
- Bachelor of Science degree or with a minimum of 5-8 years Quality experience with a manufacturing focus
- Certified Manager of Quality/Organizational Excellence - Preferred
- Previous experience in manufacturing environment - Preferred
- Knowledge of FDA regulations and cGMP guidelines
- Experience with deviation and investigations - Preferred
- Requires advanced critical thinking skills
- Must be "flexible" and capable of adapting to changes that occur due to changing business needs
skills: Quality control, SOP, FDA, Quality Assurance, GMP (Good Manufacturing Practice)
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.