Job Description

This position is responsible for ensuring the quality and compliance of products processed through the Driam coating and drying equipment. The role will focus on performing quality control checks specifically related to the Driam process, ensuring adherence to established specifications, Good Manufacturing Practices (GMP), and Standard Operating Procedures (SOPs). Depending on the needs of the organization, this role may also encompass broader Quality Assurance responsibilities, contributing to the overall quality system.

Primary Responsibilities:

• Driam Process Monitoring: Conduct in-process quality checks on products being processed through the Driam equipment, including but not limited to:
• Sampling and testing of product at various stages of the Driam process (e.g., pre-coating, during coating, post-drying).
• Verification of process parameters (e.g., temperature, airflow, coating application rates) against established specifications.
• Visual inspection of product for uniformity, coating integrity, color, and other critical quality attributes related to the Driam process.
• Equipment Inspection: Perform routine checks on the Driam equipment to ensure it is clean, in good working order, and ready for use. Report any maintenance or cleaning concerns.
• Documentation: Accurately and meticulously document all QC checks, test results, and observations in relevant logs, batch records, and electronic systems.
• Deviation Handling (Driam Related): Identify, document, and escalate any deviations or out-of-specification (OOS) results related to the Driam process. Participate in investigations and assist in determining root causes and implementing corrective actions.
• Training: Participate in training programs related to the Driam equipment, QC procedures, and GMP. May also assist in training other personnel on Driam-specific QC checks.
• Collaboration: Work closely with Production, Maintenance, and other departments to ensure smooth operation and timely resolution of quality issues related to the Driam.
• Continuous Improvement: Identify opportunities for process improvements related to Driam quality control and participate in improvement initiatives.
• Compliance: Adhere to all company policies, procedures, and GMP regulations.

In addition to the responsibilities outlined above, this role may also include:

• Documentation Review (Driam Related): Review and approve Driam-related SOPs, work instructions, and other quality documents.
• Internal Audits: Participate in internal audits, focusing on areas related to the Driam process and adherence to quality standards.
• CAPA (Driam Related): Assist in the development and implementation of Corrective and Preventative Actions (CAPA) arising from Driam-related deviations, investigations, and audits.

Requirements

Qualifications:

• High school diploma or equivalent required; Associate's or Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Food Science) preferred.
• Proven experience in a Quality Control role within a manufacturing environment, preferably in the food, pharmaceutical, or a related industry.
• Specific experience with coating and drying equipment, particularly Driam coaters, is highly desirable.
• Strong understanding of Good Manufacturing Practices (GMP).
• Excellent attention to detail and meticulous record-keeping skills.
• Strong problem-solving and analytical abilities.
• Effective communication (both written and verbal) and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in basic computer applications (e.g., Microsoft Office1 Suite).
• Ability to follow instructions and procedures precisely.

Physical Requirements:

• Ability to stand and walk for extended periods.
• Ability to lift and move objects up to (specify weight, if applicable).
• Visual acuity to perform detailed inspections.
• Ability to wear appropriate personal protective equipment (PPE).

Working Conditions:

• Manufacturing environment with potential exposure to noise, dust, and temperature variations.
• May require occasional work outside of standard business hours.

Success Factors:

• Accuracy and thoroughness in performing QC checks and documentation.
• Proactive identification and escalation of quality issues.
• Effective collaboration with other departments.
• Commitment to maintaining a high level of quality and compliance.
• Continuous learning and development related to the Driam equipment and quality systems.

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