Manager, Quality Assurance and Production
Sourcing & Production | Princeton, NJ | Full Time
Summary of Position:
Full responsibility for the hands-on quality management of Morphe required quality procedures, testing and auditing systems. This includes development and auditing of our Contract Manufacturers (CMs) Component Suppliers and their products, establishing procedures and testing, auditing protocols in line with both global regulatory requirements and Morphe QA requirements. A savvy, passionate professional with the ability to drive change and overcome obstacles to improve our Supplier Management programs. The position is for a Quality Professional with full understanding of the business and compliance priorities who is able to function with little to no supervision.
- Perform Quality System and Process Audits of Contract Manufacturers and Component Suppliers in a timely manner.
- Work closely with both Product Development and Regulatory team from beginning of new product development, through production to fully support best quality product at launch.
- Work with CS and Brand teams to gather product quality issues from the field and customers on root cause analysis and CAP mitigating risk and resolution plan for business with minimal or no business disruption.
- Establish continuous quality/process improvement programs at Contract Manufacturers’ sites.
- Initiate and track root cause analysis, CARs and PARs, for continuous improvement. Follow-up to ensure proper actions are taken and effectiveness measurements are implemented and enforced.
- Build long term relationship with CMs and ensure integration of company’s requirements in their programs & systems that are measurable.
- Ensure CMs’ compliance with regulatory requirements for all products.
- Manage all certificate of analysis, incoming & outgoing AQL inspection reports, SDS and any other testing required during development and production including stability, compatibility, etc.
- Communicate requirements and resolutions of quality issues with Contract Manufacturers.
- Interface with Packaging Engineers, Sourcing, Production, QC, Global Marketing & Product Development and Distribution Departments and provide support and participation when required.
- Participate and provide data for CM/Supplier selection, evaluation, annual re-audit and reviews
- Perform capability analysis.
- Utilize statistical and problem-solving tools such as, correlation studies, capability studies, FMEA, sampling plans and other methods as required.
- Conduct training of others (both internal and external) to ensure test procedures and work instructions are understood and applied correctly.
- Serve as a Change Agent to provide improvement solutions and gain support and buy-in from stake holders.
- Manage a quality team both overseas and in-bound warehouse QC providing guidance, leadership and support.
- Support department and organizational goals by initiating and completing projects and quality metrics with monthly, quarterly and other ad-hoc analysis and reports as needed.
- Travel internationally and domestically as required.
- All other duties as required and requested.
Required Skills & Experience:
- Bachelor's Degree in Engineering, Chemistry, Biology or related science/technical field or an equivalent combination of education and work experience.
- Minimum 3 years’ experience in manufacturing environment preferably cosmetic/pharma/food packaging with exposure to FDA and GMP regulations.
- Advance verbal and written communication skills. Demonstrates excellent interpersonal and team building skills. Technical writing skills. Organization: managing multiple requirements and deadlines.
- Ability to multi-task and work independently. Highly motivated self-starter.
- Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook. MRP, Minitab experience a plus.
- Excellent skills in decision making, data collection and analysis, organizing and planning.
- Ability to learn and apply QA tools such as Lean Six Sigma, SPC, Process Mapping, FMEA and 5S.
- Knowledge and experience in Auditing.
Must be able to perform essential functions (with or without an accommodation) without posing a "direct threat" to the health and safety to self or others.
The Company reserves the right to alter, change, abolish and even combine jobs depending upon changing conditions.
No recruitment agencies, please.