QA Specialist, In Process (OSD) job in Monroe
Vacancy has expired
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|State:||North Carolina (NC)|
Glenmark is actively seeking an In Process Quality Assurance Specialist to join the growing team in Monroe, NC. T his position will be responsible for working closely with the Glenmark Oral Solid Dosage Operations organization supporting operation preparation (e.g., line clearance) and operation "on the floor" 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 and batch release. Responsibilities within MasterControl will include Documents, Incidents, CAPA, and Change Control activities. 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.
Responsibilities Include but not limited to:
- Maintain Support quality system controls to ensure state of compliance and patient safety 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 Perform "on the floor" Quality oversight during manufacturing operations and assist Production personnel with troubleshooting.
- Perform daily regularly scheduled and as needed compliance walk-throughs in Production and Warehouse.
- Perform release line clearance and approval for use of areas/rooms for Dispensing, Sampling, Manufacturing and Packaging
- Assure Quality approval and release of raw materials and components prior to manufacturing
- Assist in control and maintain of product labels.
- Assist in maintaining Maintenance of reserve sample storage.
- Providing Quality Support during In-Process Sampling, Validation , Cleaning Verification, activities,In-Process Sampling, etc.
- Performing Real-Time timely Batch Record Review
- Initiate and aid assist in completion of the investigating of Incidents, CAPA and Change Control, as needed and Deviations
- Perform Root Cause Analysis using tools such as Fishbone, KT, 5 Whys, etc.
- Write and review Develops applicable Standard Operating Procedures (SOPs) governing Quality Management Systems, Forms, Batch Production Records, Protocols, as needed.
- Supports regulatory inspections and audits.
- Communicate results from Daily Compliance walk-throughs
- As appropriate, use knowledge and experience to solve straightforward problems.Perform problem-solving activities
- Ensures Operations Production and Warehouse activities are performed in a compliant manner 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 Bachelor's degree in scientific discipline or closely related technical field of study
- Minimum two (2) years of pharmaceutical experience in a Manufacturing or Quality role.
- Previous experience on the floor in Production (Dispensing, Granulation, Compression, Coating and Packaging, etc.) is preferred
- 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 is desirable
Knowledge & Skills:
- Proactive, results oriented, and a strong attention to detail
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
- Strong organizational, analytical, and problem-solving skills
- Ability to analyse details and perform structured decision-making
- Ability to read, write, and speak English
- Excellent verbal and written communication
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
- Knowledge of MasterControl or other electronic document system
- Knowledge of SAP (Systems, Applications & Products in Data Processing) or similar ERP system
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast-paced critical work environment
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
- Quality certifications (e.g., ASQ Auditor) a plus