Inspector I

ICU Medical•Dublin, OH

1d•Onsite

About The Position

Position Summary The Manufacturing Quality (MQ) Inspector’s responsibility will be to monitor production processes for compliance to cGMP standards. He/she will perform a variety of quality control checks to ensure appropriate utilization of equipment, commodities, product and procedures for the assigned production area. Conduct and document a variety of visual, functional and dimensional testing in support of commodity/product release – particularly in the bag fabrication, overwrap and packaging areas of production. Essential Duties & Responsibilities · Inspects materials, batch record documents and final products during the production process or off line (APQR, re-inspection, batch records). Performs and records release functional and dimensional testing. Restarts automated equipment that stopped for quality issues. · Evaluates products for defects and recognize unacceptable product. Makes decision regarding product conformity and determines if MQ batch record criteria is met. · Performs testing on commodities and final product and determines acceptance according to specifications. · Collects file samples, stability testing samples, and laboratory samples in accordance with established procedures. · Inputs data (numerical/informational) into batch records, reports and electronic data bases. Recognizes unacceptable product. Monitors production lines for irregularities and reports to area supervisor, accordingly. · Works with both internal and external customers. Shares information and provides feedback on material, operational, and mechanical related issues. · Performs mathematical calculations such as adding, subtracting, multiplying and dividing and therefore must have working knowledge of mathematical applications. · Uses good problem solving and interpersonal skills for effective communications. Follows up on activities to ensure quality is maintained. Assists in area improvements, department changes and meetings. · Follows prescribed uniform and gowning requirements. Maintains a safe, orderly, clean work environment. Reports all accidents to the supervisor. Ensures all PPE (personal protective equipment) is used, as required. · Adheres to cGMP guidelines, SOP’s and plant policies/guidelines. Assists in monitoring area for cGMP compliance. · Perform other related duties or special assignments as directed by supervisor. Knowledge & Skills · Must pass written and practical area requirements for area/certification. · Must have the ability to follow verbal and written instructions and read, understand, and communicate well with others in person and over the phone. · Must have a working knowledge of mathematical calculations, such as adding, subtracting, multiplying, and dividing. Capable of working with fractions, decimals, and percentages. Must be able to input data into a computer, as required. · Possesses good mechanical skills to handle lab equipment. · Must be able to work independently and in a team environment. Must be dependable, competent and show good attendance. · Must be a detail-oriented person. Requires strong focusing skills on in-process work activities to detect irregularities. · Adapts positively to a changing environment and/or situation. · Must be able to maintain confidentiality with personal and business information. · The incumbent will be expected to function independently with minimum supervision. Minimum Qualifications, Education & Experience · Must be at least 18 years of age · High School Diploma required · Minimum one years’ experience as a production operator or similar production or quality experience. Work Environment · The MQ Inspector position can directly impact the QA organization relative to business goals and documentation compliance. Non-compliance with government regulations (FDA, GMP, etc.), can negatively impact the organization with adverse audit observations. · Work is performed in a clean room environment · While performing the duties of this job, the employee may be required to sit or stand for long periods of time · Must be able to occasionally move and lift objects of up to 25 lbs · Typically requires travel less than 5% of the time

Requirements

Must pass written and practical area requirements for area/certification.
Must have the ability to follow verbal and written instructions and read, understand, and communicate well with others in person and over the phone.
Must have a working knowledge of mathematical calculations, such as adding, subtracting, multiplying, and dividing. Capable of working with fractions, decimals, and percentages. Must be able to input data into a computer, as required.
Possesses good mechanical skills to handle lab equipment.
Must be able to work independently and in a team environment. Must be dependable, competent and show good attendance.
Must be a detail-oriented person. Requires strong focusing skills on in-process work activities to detect irregularities.
Adapts positively to a changing environment and/or situation.
Must be able to maintain confidentiality with personal and business information.
The incumbent will be expected to function independently with minimum supervision.
Must be at least 18 years of age
High School Diploma required
Minimum one years’ experience as a production operator or similar production or quality experience.

Responsibilities

Inspects materials, batch record documents and final products during the production process or off line (APQR, re-inspection, batch records). Performs and records release functional and dimensional testing. Restarts automated equipment that stopped for quality issues.
Evaluates products for defects and recognize unacceptable product. Makes decision regarding product conformity and determines if MQ batch record criteria is met.
Performs testing on commodities and final product and determines acceptance according to specifications.
Collects file samples, stability testing samples, and laboratory samples in accordance with established procedures.
Inputs data (numerical/informational) into batch records, reports and electronic data bases. Recognizes unacceptable product. Monitors production lines for irregularities and reports to area supervisor, accordingly.
Works with both internal and external customers. Shares information and provides feedback on material, operational, and mechanical related issues.
Performs mathematical calculations such as adding, subtracting, multiplying and dividing and therefore must have working knowledge of mathematical applications.
Uses good problem solving and interpersonal skills for effective communications. Follows up on activities to ensure quality is maintained. Assists in area improvements, department changes and meetings.
Follows prescribed uniform and gowning requirements. Maintains a safe, orderly, clean work environment. Reports all accidents to the supervisor. Ensures all PPE (personal protective equipment) is used, as required.
Adheres to cGMP guidelines, SOP’s and plant policies/guidelines. Assists in monitoring area for cGMP compliance.
Perform other related duties or special assignments as directed by supervisor.