Quality Manager

Position Title

Quality Manager

Director of Operations-Liquids

ABF/L – Quality

Key accountability in Managing Quality Systems in compliance with customer specifications. Perform audits and provide reports and recommendations to senior management based on audit findings. Serve as technical expert for all Plant Quality, Validation, and Regulatory matters.

Quality Supervisor, Quality Inspectors, and Documentation Retention and Control Clerk

• All duties as assigned and the following specific activities.
• Manage a team of three or more Direct Reports with overall responsibility for Quality Assurance Department and Analytical Lab analysis/testing
• Monitors all manufacturing procedures to ensure compliance to customer’s specifications.
• Oversees inspections and ensures quality problems are identified and resolved.
• Perform and/or arrange QA/QC audits of the facility.
• Responsible for all Plant Regulatory matters including FDA, ISO, EPA, AIB, OSHA compliance and maintenance of facility and product registrations.
• Oversee investigations and corrective actions relating to product quality problems and recommends changes or improvements
• Manage all specification documentation and control
• Manage and maintain all cGMP documentation
• Interface with Customer QA Departments; serve as technical resource for all Quality and Regulatory issues
• Responsible for completing statistical analysis on all appropriate processes
• Ensure appropriate training of all departmental personnel and coordinate inter-department communications.
• Oversee preparation of and approval for all company SOP’s.
• Complete and/or verify accurate completion of all documentation (forms, reports, etc.)
• Responsible for all label storage, distribution and reconciliation.
• Insure compliance to cGMP methods and practices are being utilized in manufacturing process
• Is on call 24 hours to answer questions from 2nd and 3rd shift

• On-going outcome that is measurable
• Reduce and maintain a defects per mllion rate (DPM) of 0.50% or lower.
• On-time training execution of 100%.
• Reduce and/or maintain customer complaints to two or less per month.
• Maintain zero recall standard through quality systems and GMP
• On-time execution and closure of Questionable Material Reports, Deviations, CAPAs, Internal Audits.
• Successfully maintain ISO and FDA accredidations and certifications.

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life & AD&D Insurance
• 401(k)
• 401(k) match
• Pet Insurance
• Paid time-off
• Paid holidays
• Tuition reimbursement
• Flexible Spending Account
• Dependent Care Subsidy
• Childcare Resources
• Commuter Benefits
• Employee Assistance Program
• Disability Insurance
• Employee Discounts

Knowledge, Skills, Abilities

• BS Degree in Chemistry, Biology, Quality or related field
• Coursework in Quality, Management/Supervision/People Skills (Interpersonal Relationships).

• Minimum of Five years related industry experience
• Experience in liquid fill manufacturing and minimum three (3) years building and leading QA teams
• Experience in commercial lab settings
• Working knowledge of ISO reqs, CAPA, FMEA, etc.
• Excellent Knowledge and application of Quality System policies and procedures
• Detail Oriented
• Motivational / Team Building skills
• Ability to engage staff
• Must be able to read blueprints.

Communication:
Excellent communication skills (both verbal and written), to communicate with all personnel.

Visual Pak Companies is an Equal Opportunity Employer. Visual Pak does not discriminate on the basis of race, color, religion, marital status, age, national origin, disability, medical condition, pregnancy, gender (orientation or identification), sexual orientation, veteran status, or any other basis covered by federal, state, or local laws. All employment decisions are based on qualifications, merit, skills, individual performance, and business needs.