The Quality Assurance (QA) Manager is responsible for managing the Quality Assurance Staff in his/her designated area.

The Quality Assurance Manager will ensure compliance with company Standard Operating Procedures (SOPs) and current Good Manufacturing Practices.

The QA Manager must have the ability to work in a strong team environment and interact directly with other departments and clients.The Quality Assurance Manager will ensure all relevant Standard Operating Procedures (SOPs) and Customer protocol’s are being followed in accordance with Good Manufacturing Practices.

All deviations have to be brought to the attention of the Quality Assurance management.

Essential Duties and Responsibilities: · Applies Good Manufacturing Principles in all areas of responsibility.

· Demonstrates and promotes the company vision.

· Provide suggestions and improvements regarding work related processes and procedures· Conducts all activities in a safe and efficient manner.

· The Quality Assurance Manager must be flexible and be able to complete multitasks· Provide assistance to co-workers and other departments when necessary.

· Managing the inspection of received materials and in-process inspections.

· Managing the production quality system - Schedules QA staff in overseeing the designated operations.

- Works with line leaders and production supervisors to assure quality-oriented operations.

- Instructs QA staff in proper inspection procedures and techniques.

- Periodically reviews all aspects of packaging operations as related to quality - staging, reconciliation, in-process inspection, label control, etc.- Assures that batch paperwork is completed accurately and in a timely manner.

- Reviews packaging concerns with production management and resolves conflicts.

· Participates in and successfully completing required training sessions for CGMP’s, SOP’s, safety, quality, etc. · Provides positive and critical feedback to employees relating to their job performance.

· Completes the regular performance evaluation of designated QA · Other duties may be assigned to meet business needs.

· Occasional visits to customer sites Basic Minimum Qualifications (BMQ): Experience in GMP Manufacturing, Packaging, QA/QC, IVRS and or CRO · GCP or cGMP Knowledge/Experience· FDA/Regulatory experience a plus· Auditing experience: Internal / External processes· 2+ years in policy and or SOP writingEducation/ Experience (BMQ): Bachelor Degree or higherCertificates and/ or Licenses (BMQ): None requiredSupervisory Responsibility: Three direct reports which include a Quality Engineer and Quality Assurance technicians.

Internal and External Contacts: This position has internal contact with Production Technicians, Production Management, QA Management, Engineering, Client Services, and Logistics.

External contact - Customer representatives Ability and/or Skills (BMQ): · Excellent written communication skills· Excellent documentation skills· Communicates openly and expresses ideas and opinions· Detail Oriented· Strong verbal communication skills· Strong interpersonal skills.

· Strong organizational skills.

· Ability to perform multiple project-tasks.

· Ability to identify issues, problems or opportunities and determine whether action is needed· Listens actively and communicates openly· Dedication to meeting expectations and requirements of internal and external customers· Understands customers’ concerns and critical problems and demonstrates that solving their problems are top priority· Meets commitments and ensures that deliverables are completed on time· Establishes professional development goals· Applies new information, procedures or principles to perform job duties · Acts to preserve relationships even under difficult circumstances· Willingness to improve current standards.

· Focus on desired results · Knowledge of MS Word, Excel as well as Lotus NotesEducation: BachelorsJob Level: Manager

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