Manager Quality Assurance

Qualifications

• Minimum BA or BS in a related field
• Three (3) to five (5) years of quality assurance experience in the medical services/products area or, extensive quality science training (e.g., ASQ), with a proven understanding of people’s motivation and proven leadership potential
• Comparable experience in the food industry is desirable (in lieu of medical experience) for food irradiation facilities
• Excellent written and verbal communication skills
• Above average computer skills

Responsibilities

• Maintains compliance with all regulatory requirements to include FDA, OSHA, EPA, USDA and NRC as applicable
• Actively pursues continuous process and quality improvement as measured by internal indices and external audits/reports
• Captures and reports causes of non-conformances, implements corrective actions and process improvements; assists in appropriate retraining
• Initiates and/or oversees change control process
• Analyzes facility data for identification of trends and initiation of required actions
• Collaborates with corporate quality assurance on special projects and assignments as requested
• Coordinates facility management reviews
• Coordinates and maintains facility risk analysis
• Collaborates with plant operations on system requalification activities as applicable
• Assists in establishing departmental objectives to meet overall facility goals
• Communicates the company quality policy and values, motivating and sensitizing employees to the critical nature of our service
• Hires, retains, motivates and develops qualified personnel in QA/Validations positions, if applicable
• Provides new employee orientation, job function, GMP, safety and developmental training to employees as required by Standard Operating Procedures, Certification programs, corporate requirements and customer service initiatives
• Interacts with all functions within the plant
• Maintains all quality related training programs
• Executes Equivalency and Retrospective Revalidation studies/report where applicable
• Coordinates/executes process validations and calibrations where required
• Reviews and releases batch records for processed materials
• Assists where necessary in establishing departmental objectives to meet overall facility goals

Special Requirements

• Must be medically approved for respirator use (EO)
• Must be able to tolerate exposure to high temperature and high humidity (120F and 60% RH for 20 minutes) (EO)

Training Required

• Completes all required training for a “Quality Assurance Manager” outlined in the training manual.

Benefits

• Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
• 401(k) program with Company match that immediately vests
• Paid holidays, vacation and sick time
• Free financial planning assistance
• Paid parental leave
• Education assistance
• Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
• Employee Assistance Program (EAP)