Sr Chemist
2 months ago
Morton Grove, United States
Fareva USA
Full time
Job DescriptionJob DescriptionPOSITION SUMMARY:
Responsible for high level of expertise in chromatographic techniques (HPLC / GC), spectroscopic techniques, UV-Vis, XRF and various wet chemistry / physical testing techniques. Provide analysis and technical support and leadership to teams of laboratory associates. Provide support and enhancements to the quality systems and compliance with cGMPs, SOPs, safety and training in the laboratory.
ESSENTIAL DUTIES AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function in accordance with applicable law:
- Perform responsibilities in accordance with organization’s policies and procedures.
- Thorough knowledge of analytical chemistry which includes wet chemistry, HPLC, GC, IR, XRF, AA, UV-Vis, and KF.
- Conduct all testing assignments required by QA laboratory management in a compliant and efficient manner. Perform analytical testing of raw ingredients, finished product, stability samples and validation samples.
- Direct and ensure GMP compliance in the manufacture and testing of finished product lines.
- Supervise / mentor technicians and chemists to meet short and long term organization objectives.
- Understanding of cGMP, USP, ICH guidelines. Ability to interpret test methods as defined in monographs (USP, EP, JP).
- Review essential/critical documents for completeness and accuracy; ensure documents are compliant with Fareva's SOPs and regulatory requirements.
- Perform troubleshooting and problem solving of laboratory instruments and analytical test methods.
- Contact instrumentation vendors and assist in resolving instrument / software problems.
- Review and verify IQ/OQ and Calibration data of instruments.
- Provide technical support to internal and external customers including Packaging Units, Processing and R&D. Ensure consistency in lab operations and drive continuous improvements in laboratory performance.
- Train Technicians / Chemists on new instruments and test methods.
- Create calibration curves on instruments (HPLC / GC, UV, XRF) for new test methods.
- Evaluate and perform test methods and communicate to R&D any necessary changes or recommendations.
- Coordinate and perform process validation samples.
- Perform method validations / method transfers as needed and submit the data to R&D for final review and approval.
- Develop, run / direct, and report experiments, studies, and projects in support of production, laboratory, or other FarevaProducts group.
- Maintain effective communications with Quality Manager.
- Present data to external auditors (FDA) in the event of an audit.
- Perform periodic reviews of test methods, operating and calibration procedures as needed.
- Responsible for monitoring and ordering all necessary chemicals / solvents for use in the lab.
- Work with Unit Leader and Advisor to establish goals for the laboratory. Provide feedback to Advisors on safety, quality and productivity for laboratory associates.
- Ensure that profit plan commitments are met by efficient use of resources and careful execution of laboratory testing requirements.
- Participate in the development of laboratory procedures, validations and the training and documentation processes to support ongoing compliance to regulatory requirements and GMPs. Communicate vulnerabilities and provide leadership in developing solutions.
- Responsible for investigating Out-of-Specification test results. Perform investigational samples runs to confirm the OOS results. Participate in root cause/corrective actions and systems to ensure compliance to quality requirements.
- Manage & monitor equipment to ensure GLP compliance (i.e. system suitability, calibration, labeling, etc.). Audit laboratory records to determine compliance with Laboratory and GMP requirements. Coordinate the necessary resources to accomplish training goals.
- Perform special projects and assignments in support of the unit or facility as defined by the Advisor.
- Perform and support testing of Finished Ingredient, Contract manufacturing and Raw Ingredient sample testing.
- Perform customer complaint investigations.
- Perform verification of manufacturing documents and release of finished goods.
- Generate daily / monthly reports for quality / production management as needed.
- A Master’s degree in Chemistry (or related science) with a minimum 5 years of lab experience in cosmetic, food or pharmaceutical industry, or a Bachelor’s degree in Chemistry (or a related science) with 7 -10 years of lab experience in cosmetic, food or pharmaceutical industry.
- Demonstrated management skills and aptitude. Proven experience of explaining problems and developing solutions with operational associates.
- Proven ability of simultaneously accomplishing multiple roles such as analytical testing, training, project coordination and coaching.
- Knowledge of Good Manufacturing Practice / Good Laboratory Practice requirements.
- Demonstrated solid administrative and analytical skills. Oral and written communications skills are essential to deal with all levels of the company.
- Strong interpersonal skills due to interaction with all levels of the organization as well as with vendors / suppliers.
- Must have strong working knowledge of HPLC, GC, IR, and UV-Vis. Preferred working knowledge of XRF, AA and KF.
- Proven ability to troubleshoot analytical laboratory instrumentation and methods.
- Must be proficient in the use of Chemstation software. Ability to create test methods and calibration tables in Chemstation software.
- Preferred experience in creating new test methods and calibration tables in UV-Vis and XRF systems.
- Provide leadership and technical decisions to management regarding regulatory issues.
- Experience in test method validation and method transfer process. Knowledge of compendia method requirements and ICH method validation principles.
- Experience in developing and optimizing test methods to improve quality, reduce cost and increase productivity.
- Experience with presenting information to FDA auditors.
- Knowledge of FDA stability requirements.
- Experience in reviewing and verifying manufacturing documents.
- Must be proficient in Microsoft Word, Excel and Power Point applications.
- Possible exposure to airborne dust and chemicals associated with a micro laboratory and cosmetic processing facility.
- Possible exposure to pathogens while handling test plates and culturing microorganisms.
- Moderate safety risks associated with a light industrial environment.
- Moderate safety risks associated with steam sterilization operations.
- Walking and some climbing of stairs & walkways required.
- Must be able to lift, bend, stoop, crouch, reach and climb.
- Repetitive motion of the wrists, hands, and/or fingers.
- Ability to lift and carry up to 30 lbs. occasionally.
- Sitting for extended periods of time working in front of a computer screen.
- Standing/walking for extended periods of time.
