This position will be responsible for working closely with the Company Blow Fill Seal Operations organization supporting operation activities during manufacturing, packaging, validation, cleaning verification, etc. Assisting in the development and implementation of a harmonized processes and systems. Responsibilities within SAP will include Incident, Deviation, CAPA, Change Control initiation, raw material release. This position will also help evaluate, manage and document changes pertaining to operations and In-Process Quality Assurance. This position will actively participate in global procedure harmonization and other Quality projects as needed.
- Maintain quality system controls to ensure state of compliance and no critical and major market complaints.
- Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
- Act as Quality representative on the floor during manufacturing operations and assist Production personnel with troubleshooting.
- Perform Aseptic Gowning successfully.
- Perform daily compliance walk-throughs in Production and Warehouse.
- Perform release of rooms for Manufacturing and Packaging
- Assure release of raw materials and components prior to manufacturing
- Control and maintain product labels.
- Maintenance of reserve sample storage.
- Providing Quality Support during Validation, Cleaning Verification, In-Process Sampling, Media Fills, Vial Filling, Lyophilization, Sterilization
- Performing Real-Time Batch Record Review
- Initiate and aid in the investigating of Incidents and Deviations
- Perform Root Cause Analysis using tools such as Fishbone, KT, 5Whys, etc.
- Develops applicable Standard Operating Procedures (SOPs) governing Quality Management Systems.
- Supports regulatory inspections and audits.
- Communicate results from Daily Compliance walkthroughs
- As appropriate, use knowledge and experience to solve straightforward problems.
- Ensures Operations are compliant with SOPs.
- Use independent judgment, as necessary, in developing systems/processes for use within Quality.
- Aid in the identification of Process Improvements on a continuous basis.
- Aid in the monitoring of Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.
- Minimum Associate’s degree in scientific discipline or closely related technical field of study is required.
- 1-3 years of pharmaceutical and FDA is preferred.
- Previous experience on the floor in Manufacturing (Dispensing, Solution Prep, vial filling, blow fill seal filling, pre-filled syringes, Inspection and Packaging, etc.
- Understanding of the production processes used in the Pharmaceutical Industry.
- GMP experience is required.
- Previous Quality experience is preferred.
- Working knowledge of Lean, Six Sigma, 5S
- Excellent verbal and written communication. Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System) and/or SAP (Systems, Applications & Products in Data Processing) or similar ERP systems is a plus.
- Good communications skills, front runner, GMP trainer a plus.
- Any quality certifications a plus
1st Shift Monday - Friday 0700 to 1530 (7:00 AM - 3:30 PM)
2nd Shift Monday - Friday 1500 to 2330 (3:00 PM -11:30 PM)
3rd Shift Sunday - Thursday 2300 to 0730 (11:00 PM -7:30 AM)