External Manufacturing & Packaging QA Scientist (Germantown, MD or Remote) - Germantown, MD 20876
- We will consider remote candiadtes
Leads External Manufacturing Quality Assurance (EMQA), Packaging Quality Management (PQM), Distribution Quality Management (DQM), and Supplier Quality Assurance (SQA) initiatives for area of responsibility. Ensures that externally manufactured products, comply with the Mars Standards and FDA Regulations. -A Key aspect of this job is to ensure that External Manufacturers, Packagers, Warehouses and Suppliers in your portfolio are compliant to the MARS External Manufacturing Quality Management (EMQM) Standard, Packaging Quality Management (PQM), Distribution Quality Management (DQM) and Material Quality Management (MQM) for all services and products provided.
As the primary MSS Quality representative at External Manufacturers, Packaging Manufacturers, Warehouses, and Raw Material Suppliers they are responsible for:
- Partnering with commercial, supply, scientific regulatory affairs and food applications to drive the performance and continuous improvement of our External Manufacturers, Packaging Manufacturers, Warehouses, and Raw Material Suppliers with focus on their adherence to FDA requirements defined in 21 CFR 111, 117, & MARS Q&FS requirements and best practices to ensure that we protect our brands and corporate reputation.
- Process specific development and implementation of new products and packaging at External and Packaging Manufacturers
- Change management impacting the product compliance to quality, legal and food safety requirements.
- Assures quality and consistency of raw material, finished products, packaging material, and premia supply within Mars Symbioscience
- Manages all inbound supply risks including material quality, food safety inspections and regulatory compliance
- Responsible for External Manufacturers, Warehouses, Packagers, and Suppliers site audits, development to agreed status, approval and on-going verification
- Lead Risk Assessments to ensure that all QFS and legal hazards have been identified and effective control measures are in place
- Creates technical specification documentation for externally manufactured products, and manages the communication and approval of these documents with External Manufacturers
- Participates in line trials at the manufacturer or supplier, assessing effectiveness of all control measures and identifying necessary improvements
- Lead and execute handover to self-sufficient production status.
- Drive implementation of QMP standards, External Manufacturing Quality Management (EMQM), Packaging Quality Management (PQM), Distribution Quality Management (DQM), and Material Quality Management (MQM).
- Responsible for gathering and reporting all food safety and quality related metrics and driving necessary continuous improvement programs
- Ensures corrective and preventative actions are implemented within agreed time frames
- Implements best practices and learning from relevant serious and critical incidents within the targeted timeframe
- Applies problem solving tools such as PDCA, 5 whys, to aid root cause analysis as part of post incident reviews
- Incident owner for co-manufacturer incidents.
- Manages any incidents and non-conformities at External Manufacturers/Suppliers and, where necessary, leads the PRIMP process
- Manages the Hold & Release process. Disposition of non-conforming product and fitness for use of materials not meeting specification
- BS degree in Chemistry, Engineering or related technical field
- Minimum 3+ years’ experience in a Quality, Manufacturing, or Food Safety Industry
- Experience in auditing
- Previous experience in risk assessment and incident management
- Strong communicator and relationship builder with good commercial awareness and supplier management skills
- Proven and effective project management & organizing experience
- Visible passion, behavior and leadership around Mars first principle – Quality
- Travel up to 30% domestic (and possibly international) travel to external manufacturers
- Strongly preferred previous manufacturing experience
- Lead auditor qualified
- HACCP, ISO, quality management systems, manufacturing setting
- Basic Food microbiology, analytical chemistry and sensory methods
- Basic technological knowledge around manufacturing processing equipment
- Knowledge about Lean Six Sigma methods
- Knowledge of Dietary Supplements