Manufacturing Quality Inspector I

ICU Medical; Austin (TX); On-site; USD 30,000 - 44,000; Full time

Job summary

ICU Medical is seeking a Manufacturing Quality (MQ) Inspector in Austin to monitor production processes for cGMP compliance and conduct visual, functional, and dimensional testing in bag fabrication, overwrap and packaging areas.

Responsibilities include inspecting materials and batch records, performing release testing, entering data into records, and collaborating with internal and external customers to resolve quality issues. 3rd shift, Sunday to Wednesday, 6:00pm–4:30am.

Qualifications

• Must pass written and practical area requirements for area/certification.
• Able to read, understand and communicate effectively.
• Strong math skills for calculations.
• Mechanical skills to operate lab equipment.
• Able to work independently and in a team.
• Detail-oriented with focus on in-process work.
• Must maintain confidentiality with information.
• Independent with minimal supervision.

Responsibilities

• Inspect materials, batch records, and final products during production or off-line; perform release testing and restart equipment after quality issues.
• Evaluate products for defects and determine conformity.
• Test commodities and final product per specifications.
• Collect samples for stability and laboratory testing.
• Enter data into batch records and databases; monitor production lines for irregularities.
• Communicate with internal and external customers about issues.
• Perform basic math calculations as required.
• Support area improvements and participate in meetings.
• Adhere to cGMP, SOPs and safety rules.

Skills

Written requirements

Instructions reading

Math calculations

Mechanical skills

Independent worker

Attention to detail

Teamwork

Confidentiality

Education

High School Diploma

Tools

Lab equipment

Job description

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.

3rd shift: Sunday - Wednesday (6:00pm - 4:30am)

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