Quality Assurance Manager - Drug Manufacturing Animal Health
Our client is a leading manufacturer of animal health products, seeking a Quality Assurance Manager to support vaccine manufacturing operations.
The Quality Assurance Manager manages the Quality Assurance department and personnel in this site. The QA Manager provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change controls, procedure/manufacturing batch record changes, validations, batch disposition, and qualification activities. The QA Manager ensures product and site compliance with USDA and other country regulations and Quality Standards. The QA Manager is essential for maintaining compliance (internal and external) and providing support during internal/external inspections.
Quality Manager's Functions, Duties, Tasks:
Leads, coaches, develops, and evaluates the performance and behavior of Quality Assurance (QA); Reviews and manages employee training plans, ensuring employees are competent to perform duties.
Active member of the process team in Manufacturing to support daily operations
Provide routine and non-routine quality guidance for the process team functional area, 24/7
Review batch disposition of incoming materials, semi-finished (antigen), and finished materials (vaccine)
Serves as a site mentor and coach for all personnel on quality matters
Responsible for quality systems including; document control, batch record review and release, distribution quality oversight, sample management, etc.
Provides guidance in all areas to ensure compliance with quality systems and USDA compliance
Drives continuous improvement of all quality systems and processes
May become an alternate USDA liaison for the site who provides primary support during internal/external regulatory inspections
Communicates verbally and in writing with Regulatory Authorities as required
Participates in internal and external inspections
Effectively review/approve controlled documents to ensure quality attributes are met (i.e., non-conformances, procedures, technical studies, validation protocols, change controls, engineering documents, etc.)
Assess and triage non-conformances that occur.
Assist partners with writing change controls, deviations, and performing investigations
Responsible for the oversight of specific Quality Management systems and/or Standards as assigned
Provide a daily presence in the manufacturing environment to enable contemporaneous batch record review, provide quality guidance and expertise to production personnel, and provide trainings to production personnel and process team on quality topics.
Prepares and submits annual operating and capital improvement budget requests to meet demand.
Provides monthly metrics for site Quality Lead Team and Global network metric review meetings.
Communicates product quality problems, recommends corrective action (s), and specifies follow-up procedures.
Leads and/or participates in projects
Performs other duties as required
Minimum Qualification (education, experience and/or training, required certifications):
Bachelors degree (science or engineering degree preferred)
Must have a minimum of 5 years' experience working in Quality field
Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
Quality Manager Additional Preferences:
M.S highly desirable.
A minimum of 5 years of management experience
Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
Knowledge of or experience in Lean, Six-Sigma or Operational Excellence
ASQ certification a plus.
Experience working in an FDA or USDA regulated industry
Demonstrate strong oral, written, and interpersonal skills
Demonstrated ability to work on a team
Demonstrated decision making and problem solving skills
Root cause analysis and troubleshooting skills
Proficiency with applicable computer systems
Ability to lead without authority
Demonstrated attention to detail and ability to maintain quality systems
Technical writing skills
Strong interpersonal and team building skills; ability to lead and influence in a team environment
Quality Site Manager Other Information:
10% travel may be required
Personal Protective Equipment may be required when working in certain areas
Biosecurity environment within a manufacturing site
Security Clearance Required: No
Visa Candidate Considered: No
Manufacturing - Drug Manfacturing Animal Health
Augusta, ME, 04330, USA
June 17, 2021
June 30, 2021
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