Manufacturing Operator will assume critical role in performing activities of production oeprations in Grnules Pharmaceuticals, manufacturing facility located at Chantilly, VA. Employee must perform tasks associated to maufacturing operations as per CGMP/SOP and batch records requirements. Employee must ensure target production numbers are met and CGMP documents are completed in a timely manner and should play an active role for adherence to CGMPs and safety.
- Safety: Adheres to all workplace safety lowes, regulations, standards and practices and actively advances a culture of safety within their team and organization.
- Quality: Ensures the quality of work, products and services as a first priority; complies or exceeds all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first-time measures
- Must demonstrate ability to properly operate equipments, perform equipment set-up/change-over/cleanups, assist in preventative maintenance and troubleshoot equipment problems to achieve optimum production targets.
- Performs responsiblities ensuring compliance with GPI, polices, and SOP's and GMP and requred dcoumentation as well as performing job responsiblities in compliance with safety, health and environment standards and requirements.
- Should good knowledge of grnulation, blending/mising, compression, coating, encapsulation,etc., equipemtn and process.
- Escalates any problem occuring in the area that affects product quality, safety and other aspects of line performance.
- Perform housingkeeping/sanitization activities to maintain production areas in "inspection ready" conditions.
- Assemble, disassemble, clean and store manufacturing equipment.
- Ensure all documentation is accurate and complant with SOOs and FDA cGMP guidelines.
- Ensuring the procedurs are followed as mentioned in the bath record, SOPs protocols.
- Comply with company policies and procedures.
- Other duties as assigned by management
Knowledge & Skills:
- Solid knowledge of fundamental cGMP and safety requirements in a pharmacuetical manufacturing environment
- Experience in any of the following areas: Dispensing; Granulation; Blending; Compression; Coating and Encapsulation
- Good interpersonal skills with the ability to work as part of a high-performance team
- Successful completion of the literacy and numeracy evaluation
- Strong mathamatical and organizational skills
- Good communication skills both written and verbal are essential
Experience & Education:
High School Diploma or equivalent experience
1-3 years solid dose production operator experience or previous experience
Any production or retail store experience
Knowledge of Good Manufacturing Practices (cGMP)
Looking for Pharmaceutical Glatt, Compression and Pan coating experience
This position requires the ability to do heavy lifting/bending frequently
Must be able to life and/or move up to 50 lbs with or withour reasonable accommodations
Must be open to work any shift that is necessary depending on the business needs
Able to stand/sit for long periods of time