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Description
Position Summary:
The Quality Inspection Specialist is responsible for performing physical inspection of card batches on the productiOn Floor, supports quality walkthroughs of production areas and changeovers between batches (as applicable).
Primary Responsibilities:
Utilize AQL sampling guidance to inspect cards, pouches, and cartons for physical anomalies or rejects.
May support containment of rejected materials.
Supports nonconformance investigations using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.) as required.
Perform walk throughs to support technicians in comments, quality decisions, and procedure questions.
Implements and completes continuous improvement projects as required.
Collaborate with Final QC lab for card inspection results.
Position Requirements:
High school diploma required
In lieu of a Bachelor's Degree, an Associate's Degree with a minimum of 4+ years of progressively responsible and related experience working in a FDA regulated, GMP production facility.
4+ years of experience working in a GMP production environment
Exhibits strong analytical and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize Quality Engineering tools and techniques effectively.
Experience working in an FDA regulated, GMP environment with knowledge of Good Documentation Practices is required. (≥ 4-5 years)
Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
Strong interpersonal skills and ability to work with all levels of an organization.
PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.
Prior knowledge of MES, SPC, or SAP a plus
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
Description
Position Summary:
The Quality Inspection Specialist is responsible for performing physical inspection of card batches on the productiOn Floor, supports quality walkthroughs of production areas and changeovers between batches (as applicable).
Primary Responsibilities:
Utilize AQL sampling guidance to inspect cards, pouches, and cartons for physical anomalies or rejects.
May support containment of rejected materials.
Supports nonconformance investigations using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.) as required.
Perform walk throughs to support technicians in comments, quality decisions, and procedure questions.
Implements and completes continuous improvement projects as required.
Collaborate with Final QC lab for card inspection results.
Position Requirements:
High school diploma required
In lieu of a Bachelor's Degree, an Associate's Degree with a minimum of 4+ years of progressively responsible and related experience working in a FDA regulated, GMP production facility.
4+ years of experience working in a GMP production environment
Exhibits strong analytical and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize Quality Engineering tools and techniques effectively.
Experience working in an FDA regulated, GMP environment with knowledge of Good Documentation Practices is required. (≥ 4-5 years)
Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
Strong interpersonal skills and ability to work with all levels of an organization.
PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.
Prior knowledge of MES, SPC, or SAP a plus
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics' application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
