Production Tech IV Inspection - NW Indy
- Immediate Opportunities - Life Sciences
- IN, USA
- Full Time
- Full package of benefits
Production Tech IV - Inspection - NW Indy
EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking candidates for the Production Tech IV Inspection position.
Individual is responsible for the execution of the Visual Inspection Program in operations. The employee will ensure that this program is executed according to Standard Operating Procedures and compliant with CGMP regulations. The individual will regularly review the program and work with technical and quality groups to ensure that the program is in a constant state of improvement.
Major Position Activities & Responsibilities:
• Have demonstrated expertise in one or more of the following functional areas: Previous work experience in Clean room/Aseptic environments, Equipment Preparation, Stopper Preparation, Inspection (semi-automated and manual), Packaging Operations, Sanitization of Classified Areas and Operation of Autoclaves.
• Train inspection Operators on visual inspection.
• Ensure all Inspection Operators execute tasks according to Standard Operating Procedures.
• Ensure all Visual Inspection Procedures are up to date, meet requirements of cGMPs and identify/implement opportunities to improve Visual Inspection Program.
• Ensure all Visual Inspection equipment is in a state of validation prior to use.
• Collaborate with Validation group in the maintenance of defect sets, qualification defect sets, and the particle library.
• Perform final batch record reviews prior to QA review.
• Liase with Technical Support and Quality functions to improve the visual inspection program, as well as resolve issues generated during the manufacturing process.
• 4-year college degree plus 1 or more years of relevant experience or 2-year degree plus 4 years relevant experience, or 10+ years of relevant experience. Degrees in a technical area of study (i.e. biology, chemistry, engineering, etc) are preferred.
• Minimum of five years of experience using current Good Manufacturing Practices (GMP) within an aseptic environment of a regulated manufacturing facility (pharmaceutical/biotech/diagnostic industry).
Strong verbal and written communication skills to read, comprehend, discuss and write detailed GMP documentation (batch record instructions, Standard Operating Procedures, etc.).
As persons in this role are engaged in the open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
Must possess adequate working knowledge of arithmetic functions to accurately perform or check calculations required in the product documentation.
Possess presentation and assertiveness skills adequate to lead and train others.
Consistent positive influence on co-workers, leading by example.
Demonstrated commitment to high quality work.
Initiative and experience to anticipate area needs and do more than required.
Demonstrated good judgment regarding utilization of company resources.
Catalyst for change and continuous improvement/development.
Leadership experience in training/directing others preferred.
Demonstrated mechanical aptitude.
Computer skills in Microsoft Office such as Word and Excel are required.
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