What are the responsibilities and job description for the Quality Coordinator I position at Cremer North America LP?
Quality Coordinator
This will be an off-shift position (2nd or 3rd shift)
Why work for us
- Competitive 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 Required
Kind & Length of Experience:
- 1 or more years of progressive experience in a manufacturing or warehouse environment is preferred
- Experience with International Standards Organization (ISO) 9001, Good Manufacturing Practices (GMP), International Pharmaceutical Excipients Council (IPEC), Global Food Safety Initiative (GFSI), and other quality programs preferable
- Technical writing experience is preferred
- Experience working an off shift in a previous role is required
- Proven attention-to-detail and decision-making skills in a scientific environment are required
- Proficiency in Microsoft Office is required
PERFORMANCE 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 analysis
- Perform 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 processes
- Quality internal auditing
- Nonconformance, corrective/preventive action
- Adhere 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.
