Logo
Cremer North America LP

Quality Coordinator I

Cremer North America LP, Cincinnati, Ohio, United States, 45208


Quality Coordinator

This will be an off-shift position (2nd or 3rd shift)

Why work for usCompetitive benefits including

Medical, Dental, Vision, 401K match, and a few others!You are eligible to participate in Cremer's profit-sharing program.

This can pay out up to 9% of your annual income.POSITION SUMMARY

The Quality Coordinator is responsible for the maintenance of critical QC processes within the manufacturing operation as assigned. The QCI utilizes critical thinking and attention-to-detail skills to check, measure, monitor, and record production to a specific quality standard. Each QC will perform assigned QC checks in a timely manner and ensure that all assigned checks meet the defined frequency throughout each production run on the specific line. The QC will work with the Quality Assurance Manager to ensure that production lots are ready for release. In addition, the person will be auditing the line leads and operators to ensure competency. They will work with all levels of management and associates to facilitate problem solving and ensure customer quality standards are achieved.

POSITION REQUIREMENTS

Education, Credentials, Licenses:

High School Diploma or GED RequiredKind & Length of Experience:

1 or more years of progressive experience in a manufacturing or warehouse environment is preferredExperience with International Standards Organization (ISO) 9001, Good Manufacturing Practices (GMP), International Pharmaceutical Excipients Council (IPEC), Global Food Safety Initiative (GFSI), and other quality programs preferableTechnical writing experience is preferredExperience working an off shift in a previous role is requiredProven attention-to-detail and decision-making skills in a scientific environment are requiredProficiency in Microsoft Office is requiredPERFORMANCE MEASURES AND STANDARDS

Ensure that 100% of each production is checked according to the quality requirements for the production to be released.Assist Quality Assurance and operations to investigate quality issues, complaints, or product returns.Communication of quality requirements, non-conformances, and quality training during huddles and monthly team meetings.Support production in investigations by root cause analysisPerform key audits of the line leads.Audit operators' skills and competency during the operations.Pull production lot retains for each lot per procedure.Work with Quality Assurance Manager to ensure production meets PCNA & customer quality requirements.Support the following company programs:Document and record control for quality related processesQuality internal auditingNonconformance, corrective/preventive actionAdhere to all Environmental, Health, Safety, Security Requirements covered under Local State and Federal Regulations.Follow all RC14001 guiding principles, policies, procedures and other requirements.Maintain Hazardous waste in accordance to all Local, State and Federal Regulations.Ability to travel frequently up and down stairs.Other quality control duties as requested.

We are an equal opportunity employer. Applicants are considered for positions without regard to sex, race, color, ancestry, religion, national origin, disability, age, marital status, disabled veteran or Vietnam era veteran status, genetic information, sexual orientation, pregnancy, including childbirth or any related condition, gender identity or expression, citizenship, or any other characteristic protected by applicable state, federal or local laws.