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About the Role
The Manufacturing Quality (MQ) Inspector monitors production processes for compliance with cGMP standards, performing quality control checks to ensure proper utilization of equipment, commodities, product, and procedures. This role involves conducting visual, functional, and dimensional testing, particularly in bag fabrication, overwrap, and packaging areas.
Responsibilities
- Inspects materials, batch record documents, and final products during or after the production process.
- Performs and records release functional and dimensional testing.
- Restarts automated equipment that stopped due to quality issues.
- Evaluates products for defects and determines conformity to standards.
- Performs testing on commodities and final product to determine acceptance according to specifications.
- Collects file samples, stability testing samples, and laboratory samples.
- Inputs data into batch records, reports, and electronic databases.
- Monitors production lines for irregularities and reports them to the area supervisor.
- Works with internal and external customers, sharing information and providing feedback.
- Performs mathematical calculations including addition, subtraction, multiplication, and division.
- Uses problem-solving and interpersonal skills for effective communication.
- Follows up on activities to ensure quality is maintained.
- Assists in area improvements, department changes, and meetings.
- Follows uniform and gowning requirements.
- Maintains a safe, orderly, and clean work environment.
- Reports all accidents to the supervisor.
- Ensures all required personal protective equipment (PPE) is used.
- Adheres to cGMP guidelines, SOPs, and plant policies.
- Assists in monitoring the area for cGMP compliance.
- Performs other related duties or special assignments as directed by supervisor.
Requirements
- Must pass written and practical area requirements for area/certification.
- Must have the ability to follow verbal and written instructions.
- Must be able to read, understand, and communicate well with others in person and over the phone.
- Must have a working knowledge of mathematical calculations, including fractions, decimals, and percentages.
- Must be able to input data into a computer.
- 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.
- Expected to function independently with minimum supervision.
- Must be at least 18 years of age.
- Must be able to occasionally move and lift objects of up to 25 lbs.
Skills
- cGMP compliance
- Visual testing
- Functional testing
- Dimensional testing
- Problem-solving
- Interpersonal skills
- Mathematical calculations
- Data entry
- Mechanical skills
- Teamwork
- Attention to detail
- Adaptability
- Confidentiality
Location
- Onsite
Work Type
- Full-time
- 3rd shift
Experience Level
- Minimum one year of experience
Education Level
- High School Diploma
About the Company
- We manufacture the critical IV solutions providers count on to deliver consistent, reliable care.
- Each product we make helps ensure patients receive the therapies they need without disruption.
- When you work here, you become part of something bigger—a team dedicated to reliability and innovation.
- No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.
- We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
- Join us and help shape the future of IV solutions.
Equal Opportunity
- Otsuka ICU Medical is committed to being an Equal Opportunity Employer.
- We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
- If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at austinhr@icumed.com.
- We are committed to providing equal access and opportunities for all candidates.
- Otsuka ICU Medical EEO Policy Statement
- Know Your Rights: Workplace Discrimination is Illegal Poster
- Otsuka ICU Medical CCPA Notice to Job Applicants