Senior Chemist - Kennesaw, GA
The Senior Chemist is responsible for ensuring samples from all phases of manufacturing or other handling process are prepared and tested according to specifications. This individual will employ a variety of methods and will require intermediate laboratory skills, as well as a thorough understanding of analytical testing equipment and processes. They will prepare and authorize documentation for the release of raw materials and finished goods and will play an active role in project implementation and documentation. He or she is also responsible for technician proficiency, training, interpretation of methods and results, and minor equipment troubleshooting and repair. They will play a role in preserving workplace safety and safe potentially hazardous materials handling. MAJOR ACCOUNTABILITIES
The responsibilities of the Senior Chemist include but are not limited to, the following:
Testing and Reporting
Test submitted samples under cGMP/GLP environment as per company's standard operating procedures and USP/FDA guidelines.
Assist Lab Administrator with scheduling analytical tests and/or experiments and ensure adequate coverage to meet commitment dates.
Provide expert opinions and interpretation of analytical assay results.
Provide expert opinions and interpretation of OOS results and guide the decision making and documentation process for Laboratory Error Investigations, nonconformances, and deviations.
Review and approve the interpretation and documentation of results generated by QC Chemists
Ensure analytical results are appropriately documented and reported in a timely basis.
Maintain up to date documentation. Enter all raw data directly into the notebook and promptly calculate all test results.
Peer review notebooks and test results generated by QC Chemists
Prepare and update COAs as needed
Inventory and Equipment
Ensure reagents, substrates, and kits are prepared according to procedures and are readily available for testing.
Ensure adequate inventory of lab supplies to conduct analytical assays while working within the provided budget
Maintain laboratory equipment and instrumentation in good working order, following appropriate procedures for usage, clean-up and maintenance.
Ensure cleaning and use, verification, and maintenance logs are kept up to date and clearly represent the actual history and current status of each piece of equipment.
Provide input and feedback for design requirements for new and/or replacement equipment
Schedule and assist equipment repair technicians.
Assist Lab Manager with development of Capex requests.
Training and Proficiency
Develop and execute training plan for QC Chemists on methods and technique.
Oversee and schedule laboratory proficiency testing as required by ISO 17025 standards.
Ensure QC Chemists are appropriately trained on all assays for which they are scheduled
Determine the proficiency status of QC Chemist.
Method Optimization and Validation
Review validation results and investigate non-conforming values.
Optimize methods and investigate matrix interferences for documentation of exemptions
Oversee implementation of new methods
Conduct and determine uncertainty measurements as required by ISO 17025.
Submit change control requests for methods or procedures that need to be added, revised, or updated to ensure equipment and methods are performed in a manner to minimize uncertainty and variability.
Review and provide feedback on standard operating procedures, forms, and documents.
Management
Lead chemistry department with effective mentoring, directing and coordination of development activities
Communicate and enforce laboratory quality requirements to personnel working in the lab and ensure that they are completed per GMP, GLP and ISO 17025 standards
Lead and facilitate initial and periodic training of QC Chemists to ensure standard laboratory practices, techniques, and adherence to cGxP and other applicable regulations and standards (21 CFR, §11, §111 and §117, ISO17025 and the requirements of TGA PIC/s)
Assist with preparation and delivery of personnel evaluations and competencies.
Assist with improvement plans/disciplinary action where necessary
Coordinate objectives with production procedures in cooperation with other managers to maximize product reliability and minimize costs Additional Qualifications/Responsibilities Education and Experience
Minimum - Bachelor of Science in Chemistry, Biology or equivalent
Minimum - 2 years of experience in an Analytical Lab conducting assays
Specific Skills
Strong attention to detail in order to produce accurate, precise, and reproducible data
Strong analytical, organizational, and time management skills
Task oriented and results driven
Strong work ethic and prioritization skills
Work collaboratively with various departments to compile, analyze, and interpret data
Manual dexterity
Ability to follow written protocols
Ability to work in a fast paced environment
Excellent written and oral communication skills - ability to make presentations and/or give presentations
Must be able to lift 25lbs
Must possess a valid US Driver's License ADM requires the successful completion of a background check. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. If hired, employees will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. The pay range for this position is expected to be between: $39,200.00 - $72,800.00
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