DETAILED JOB DESCRIPTION
- Perform all required in-process testing & sampling of batches in progress and products to be packaged.
- Perform line clearances of the manufacturing/ packaging areas and equipment
- Verify and confirm issuance and reconciliation of product and components.
- Performing cleaning verification/validation swabbing of equipment
- Verify that temperature/humidity, D.I. Water and Magnehelics are all in range/good working condition
- Handle various requests from departments for developmental or investigative reasons
- Capture critical information for Customer Complaint/Deviation investigations/ CAPA (when necessary)
- Review and approve preventive maintenance or work orders; (if necessary)
- Participate in stability/validation product sampling
- Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves.
- Complete all applicable training forms in a timely manner and forward to document control for archival
- Data entry of finished product information into the APR (Annual Product Review ) system
- Collection and inventorying of Retain and/ or Stability Samples
- Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)
- Replace Temperature/Humidity Charts weekly if applicable
- Maintaining IPQA supply inventory
- 1-3 year experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
- Must be a team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals
- Be able to work long hours to support production requirements
- Be available for overtime, including weekends, as needed for production support
- Possess the ability to analyze information and make consistently good decisions
- HS Diploma
- Experienced in proper documentation and correction practices
- Read, write and speak English
- A familiarity with cGMPS, CFRs, OSHA and FDA regulations
- Experience with deviations /incidents and CAPA
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
- Stand/walk for the majority of the shift
- Must be able to bend at the waist and knees as well as twist at the trunk
- Must practice good personal hygiene
- Must be able to lift up to 30 lbs.