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Responsible for directing all aspects and activities associated with Compounding of all Trojan condoms dipped in the Colonial Heights facility.
RESPONSIBILITIES: *denotes essential job functions
*Arrange daily/weekly/monthly latex and lube compounding production schedules along with new product trials and qualifications in the most cost-effective manner and still meet production and budget goals.*Manages Latex ordering, latex inventory and lubricant inventory.*Directs the Dipping and Compounding Departments to assure the necessary processing of compounded latex and lubricants needed to keep Dipping, Apollo and Combo production operations running.*Determine the compounding parameters for each batch.*Measures Compounding risk for each latex lot.*Decides the percentage of solids target for each latex lot.*Develops test plans and schedules at the request of R&D for new product design and development.*Establish an algorithm for assigning compound latex to dip line reserve tanks.*Supports all Dipping and Compounding production equipment. Alerts manager and supervisors if operating efficiently.Supports preventative maintenance, data collection, reliability programs to meet quality and production requirements.Directs procurement of necessary supplies and material needed to support compounding and production activities.Prepares various reports including monthly department activity, inventory, production and capacity, inventory control, weekly and monthly quality requirements.Prepares and maintains IPABT statistical data. Month end IPABT results.Oversees and coordinates work with R&D, GNPI and consultants as needed. Supports continuous improvement tools, Lean, root cause analysis and cost reduction activities.EDUCATION: MINIMUM REQUIREMENT
B.S. degree in a science discipline.
ASQ, Lean, Six Sigma or equivalent certification is a plus.
EXPERIENCE: MINIMUM REQUIREMENT
0-5 years of experience in Medical Device, food, drug or other FDA / GMP regulated facilities.
Prefer demonstrated use of Quality tools/methodologies including DOE, FMEA, CAPA, complaint investigation and trend analysis, process validation (IQ, OQ, PQ).
Possess a thorough understanding of statistical analysis and sampling plans.
Prefer familiarity with Medical Device industry regulations including FDA QSR’s, EN 46001, ISO 13485 and the Medical Device Directive.
SPECIAL SKILLS:
Excellent verbal and written communication skills are a must.Ability to design, evaluate, troubleshoot and improve manufacturing practices is a plus.Understanding of business operations is a plus.SPECIALIZED EQUIPMENT USED:
Microsoft Office 365 (Excel, Microsoft Word, and Outlook) software is a must.Must have intimate knowledge of production latex or chemical compounding equipment (pumps control valves, compounding kettles, agitators, etc). Prefer experience with high speed thin wall latex dipping product equipment.Must have a working understanding of the Compounding manufacturing process equipment (pumps, control valves, agitators, etc.).COMMENTS:
This person must be able to work independently in a fast-paced environment and also have the personal skills to work within a team environment.
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