Quality Manager
- 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
- 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.
- Excellent communication skills (both verbal and written), to communicate with all personnel.
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