Senior Manufacturing Technician - First Shift

SENIOR MANUFACTURING TECHNICIAN POSITION SUMMARY

The Senior Manufacturing Technician is responsible for supporting all activities associated with the set up and operation of the production equipment to manufacture, process, and assemble various commercial products and substances. 

Monitors output for quality and conformance to required metrics. 

Prepares and maintains required records of production activities and reports any inconsistencies or equipment issues at the KDD Lexington facility.

ROLE RESPONSIBILITIES

• Be knowledgeable of and able to perform all job functions of the manufacturing process, as required.
• Review and revise batch records for completeness and accuracy.  Maintain control of product and materials to aid in successful completion of accountability.
• Fully trained to execute critical manufacturing operations.
• Collaborate effectively with Quality Assurance and technical subject matter experts from other support departments to ensure Manufacturing commitments are completed in a compliant manner.
• Conduct and/or assist with training of new employees.
• Participate in continuous improvement event/activities.
• Execute on-the-floor investigation triage and perform root cause analysis.  Investigation and ownership of Quality System work such as deviations, complaints, OOS, OOT, etc. 
• Review process, product and equipment related validation and stability protocols and reports
• Technical review of Batch Records, SOPs, and manufacturing processes.  Develop and implement process improvements
• Required to work with some supervision by senior staff and with other departmental or non-departmental personnel.
• Participates in Manufacturing Process Improvement Teams
• Other assigned responsibilities as established by Manager.

BASIC QUALIFICATIONS

• High school diploma or general education degree (GED) with a minimum of 4-6 years related GMP experience and/or training required; Associates or Technical degree preferred 2-3 years production supervision experience desired.  Lean manufacturing, continuous improvement experience preferred.
• Must be able to read and comprehend instructions, correspondence, and technical documents. Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
• Ability to use computer programs such as Access, Excel, ERP, Power BI, Power Aps and an electronic document management system.
• Must have strong attention to detail.
• Must demonstrate the ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form.
• Must follow and review detailed documentation for accuracy and completeness.

• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Strong communication skills (written and verbal) and strong organizational skills.
• High level of personal/departmental accountability and responsibility.
• Ability to work in a team environment and to work within that team to maximize efficiency and throughput.

PHYSICAL QUALIFICATIONS

• The employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls. 
• The employee is regularly required to stand and walk; climb or balance; and stoop, kneel, or crouch. 
• The employee must occasionally lift and/or move up to 60 pounds. 
• The employee must wear all required safety equipment and perform assigned work in a safe manner. 
• The employee must use proper lifting techniques and be conscious of hazards around him/her. 
• Must follow all GMP and safety procedures within the department.

OCCUPATIONAL EXPOSURE/RISK POTENTIAL

Work environment includes the ability to work with high potent chemical compounds, hazard materials, toxics, and control substances.  Must be willing to adhere to stringent PPE requirements, safe work methods and practices for personal and product protection.  Attention to detail instructions and following other safe practices are key requirements as well. Medical surveillance protocols and questionnaires may be part of some of the products to be manufactured.