Microbiologist

• Utilize team approach with lab technicians to accomplish projects, ensure quality of microbiological analysis and provide training where needed.
• Responsible for method development, validation and optimization.
• Develop and evaluate new or revised procedures using methodology and in-depth understanding of testing procedures;
• Evaluate Plant needs for in-process and finished product testing, implement and perform testing.
• Provide technical support to plant and customers.
• Coordinate contract laboratory testing as needed, interpret and communicate results.
• Evaluate testing, calibration and other lab methods for validity and provide input for improvement
• Provide general lab support by maintaining effective inventory control of lab equipment and consumable supplies and follow up on maintenance work orders.
• Investigate and make recommendations with respect to plant and complaint investigations through the use of records, experimentation and technical knowledge;
• Provide training support for entry level technicians as necessary;
• Develop laboratory SQC systems and implement into daily operations.
• Implement the use of statistical techniques to maintain QC laboratory ISO 9000 compliance and ME projects.
• Plant Quality Improvements – represent quality on plant quality improvement teams. Work with engineers, operators and other team members to complete projects.
• Prepare monthly and annual reports to support process engineering, production and ISO 9000 data and trend analysis requirements for products and test methods.
• Ensure lab and plant compliance to cGMP & HACCP and FDA guidelines.
• Write and update SOPs to comply with Compendia and regulatory.

• Ensure all operations are carried out in accordance with, Quality&Food safety policies and practices.
• Ensure Work Instructions are developed and followed for all operational processes.
• Ensure that production process and environment compliance with Quality, cGMP&HACCP.
• Participate in site quality programs, behavioral based quality&food safety activities, audits and risk base on quality&food safety activities as required.
• Model behaviors that demonstrate a high regard for the quality, food safety, safety and health of individuals and the site as well as the environment.
• Encourage high level of quality&food safety, safety participation and commitment from others.
• Comply with external and internal requirements and regulations (DuPont, cGMP&HACCP, ISO 9001, FSSC 22000etc).
• Follow cGMP&HACCP Practice.
• HACCP -Haccp Team member, support lab test result.
• Monitor Product/Material quality test result base on Food safety program.

• Review Microbiological test result of material and product.
• Responsible for microbiological lab equipment calibration program.
• Responsible for lab performance and Proficiency Test.
• Support quality improvement project and plant trial run.

• Ensure all operations are carried out in accordance with safety, EHS policies and practices
• Participate in site safety programs, behavioral based safety activities, audits and emergency response activities as required.

• Ensure cost conscientious is a major consideration in utilization of laboratory materials and equipment
• Ensure correct purchasing procedures are followed when purchasing goods or materials on behalf of the company
• Support Manager in the budget process by providing information as required.

• 3-5 years experience in an analytical, microbiology lab, quality control or equivalent in Food Manufacturing or pharmaceutical environment.
• Experience with basic laboratory equipment and analytical testing procedures;
• Experience with microbiology protocols and biohazards.
• Experience with basic laboratory for pharmaceutical product
• Experience with Quality System management ISO 9001, cGMP & HACCP, FSSC 22000, pharmaceutical quality management and EXCiPACT is preferred.

• Formal statistical training and demonstrated ability to apply statistical techniques to laboratory methods and plant processes;
• Demonstrated ability to apply chemistry concepts to solve problems;
• Knowledge of QC techniques and experience with ISO17025, ISO9001, cGMP & HACCP, FSSC 22000.and USP quality requirements relative to pharmaceutical excipients and food additives;
• Excellent computer skills and software knowledge, including proficiency in programs such SAP, Microsoft Office, LIMS systems.
• Highly organized and self-motivated;
• Ability to work in a fast-paced environment while maintaining quality requirements and meeting deadlines;
• Excellent interpersonal skills. Ability to function both as a leader and a team player;
• Strong oral and written English communication skills. Ability to effectively communicate at various levels of the organization, with demonstrated attitude of respect towards others;
• Overtime and occasional weekend work as required to complete testing and projects in accordance with business and customer demands.

Kensington Associates Recruitment