Quality Assurance Manager
|Title:||Quality Assurance Manager|
Immediate need for a Quality Assurance Manager
Duration: 12+ Months
Location: Allentown, PA
- Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Establishes procedures for maintaining quality standards.
- Provides leadership in promoting and enforcing company quality requirements.
- Evaluates and develops techniques designed to maintain awareness of SOP’s, CGMPS’s and clinical requirements.
- Develops and manages Quality Assurance systems that will enhance and maintain products that meet quality specifications and standards.
- Leads and successfully completes QA training sessions for CGMP’s, SOP’s, company requirements, etc.
- Understanding of Regulatory requirements with respect to distribution of pharmaceutical product.
- Experience in Good Distribution Practice (GDP) in relation to temperature controlled cold distribution, frozen distribution, and shipment.
- Direct QA Supply Chain personnel in appropriate inspection procedures and techniques.
- Completes the regular performance evaluation of QA Inspectors.
- Assures that issues potentially affecting product quality/compliance are escalated to the attention of Senior Management.
- Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
- Conducts all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
- Bachelor’s degree
- A minimum of 4 years of experience in Pharmaceutical or of a related, regulated industry and at least 2 years supervisory experience required.
- Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others), people management.
- The individual must be able to perform each essential duty satisfactorily.
- Experience mentoring junior staff and good conflict management skills.
- Must have strong project management, statistical analysis, and communication skills
- Must have good working knowledge of cGMP Regulations
- Organizational skills are required in order to quickly retrieve needed documents
- Extensive standing and walking on packaging floor in order to monitor room activities.
- Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
- The employee must occasionally lift and/or move up to 20 pounds.
- Proficient communication skills (both verbal and written)