What are the responsibilities and job description for the ST Lab Coordinator position at Cremer North America LP?
Lab Coordinator
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
Reporting directly to the Laboratory Services Manager, the Laboratory Coordinator serves as the point of contact for data reporting, COA generation, and laboratory approval for product release. This position is accountable for the entire laboratory documentation, labeling, and administration process. The Laboratory Coordinator shares responsibility with the Lead Analyst for supporting management by assisting with laboratory expense, data projects, and laboratory QA assessments. This role also maintains consistent involvement in sample qualification as an analyst.
POSITION REQUIREMENTS
Education, Credentials, Licenses:
- Science oriented B.A or B.S. degree or higher in a related discipline or equivalent combination of experience and education
Kind & Length of Experience:
- The individual must have 4 years of progressive experience in a GMP manufacturing or laboratory environment.
- Experience with GMP, ISO 9001, ISO 17025, SQF, and other quality programs preferable.
- Proven attention-to-detail and decision-making skills in a scientific environment.
- Effective oral and written communication skills.
- Proficient with Microsoft Excel
- Power BI experience preferred
- Training experience is preferred
- Experience with continuous improvement and auditing is preferred
- Position requires standing on feet most of the day and some climbing of stairs.
- Should be able to lift up to 30 pounds.
- Ability to visually discern color is required
- Ability to distinguish odor and fragrance types is required
- Full dexterity with hands and arms.
- Ability to wear required personal protective equipment which may include nitrile gloves, face shields, safety glasses, steel toe work shoes, aprons or lab coat.
PERFORMANCE MEASURES AND STANDARDS
- Responsible for the laboratory documentation, labeling process for the laboratory according to Good Documentation Practices.
- Ensure that all laboratory data is properly entered, reviewed and reported correctly in identified software platforms to effectively generate Certificates of Analysis.
- Responsible for the laboratory COA templates and accuracy. Serves as Business Central COA module expert.
- Responsible for the execution and maintenance of the laboratory management system as it relates to certification standards and regulatory requirements (ie. ISO 17025, SQF, cGMP, ISO 9001, etc)
- Ensure that all Laboratory Specifications (formula cards) are up to date for each customer in Business Central.
- Facilitate Out-of-Specification or Out-of-Calibration process as needed and notify internal customers and management when potential issues arise, or material does not meet specification.
- Has the authority and responsibility to identify any deviations from the laboratory management system or from the procedures for performing laboratory activities.
- Responsible to initiate any corrective or preventative actions to prevent or minimize such deviations.
- Assists Total Quality Manager in gathering data and documentation during investigations, change controls, deviations, or risk assessments. Writes corresponding documentation as needed.
- Monitor and ensure that sample data requests are performed within a timely manner.
- Shared responsibility with Lead Analyst for assuring lab supplies and chemicals are ordered as requested by laboratory team.
- Works with CNA Laboratory management to monitor and report financial and KPI results including: testing charges to invoice, possible laboratory expense issues, sample volume, and CoA defects. Reports to management when testing or COA deadlines are not being met by team.
- Communicates with the Integrated Supply Chain team to understand shipment priorities to translate into laboratory testing and COA generation priorities.
- In your absence you are to ensure that the tasks assigned to you are adequately covered by trained personnel. You are responsible to communicate and work with your manager to ensure your workload is covered when you are out.
- Document control;
- Records control;
- Management of change;
- Internal audit;
- Nonconformance, corrective/preventive action; and Monitoring/measurement/calibration of lab equipment.
- Support efforts to implement and maintain ISO17025 for the present scope or future scope, as needed.
- Adhere to all environmental, health, safety, and security requirements covered under local, state, and federal regulations;
- Follow all RC14001 guiding principles, policies, procedures, and other requirements.
- We will follow the company written training program for this position.
- Laboratory Management ensures that personnel have the competence to perform lab activities for which they have been assigned and to evaluate the significance of deviations.
- Laboratory Management communicates to personnel their duties, responsibilities, and authorities.
- Laboratory Management assigns and authorizes lab personnel to perform specific laboratory activities including, but not limited to:
- Development, modification, verification, and validations of methods and procedures.
- Analysis of results, including statement of conformity or opinions and interpretations.
- Report, review, and authorize results.
- Other duties as assigned
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.
