Qc Chemistry Specialist

Union Agener•Augusta, GA

20h

About The Position

Position Description, Functions, Duties and Tasks: Responsible for maintaining a safe work environment and working safely Experienced in testings which includes use of the following: HPLC (reversed-phase, size-exclusion), SDS-PAGE, Karl Fischer titrimetry, In-vitro dissolution, Particle size analysis, UV/Vis spectrophotometry, atomic absorption spectrophotometry Conduct raw material testing to compendial standards (USP/EP/JP) Suport routine and non-routine testing, troubleshooting, and method diagnostics. Assist with method validation to ensure methods remain reliable and compliant Manage and Coordination of Chemistry Modular Training Program Conduct training for Chemistry Lab Personnel and/or coordinates training schedules Manage method training qualification process to ensure individuals maintain method proficiency and qualification Assist with CAPAs, efficiency projects, and instrument IQ, OQ, and PQ Assist with non-routine sample request testing Effectively communicates with plant personnel, vendors and QC team members Provide technical understanding of regulations applicable to laboratory testing for cGMP purposes Assist with scheduling of testing and review Assist with Chemistry lab scorecard and metrics Provide support for the site during Quality Audits as needed Review and approve in process results through LIMS or other controlled systems Perform other tasks as assigned by QC Manager Minimum Qualification (Education, Experience and/or Training, Required Certifications): B.S. degree in Chemistry, Biochemistry, or related field Additional Preferences: 5 years of demonstrated experience in a GMP laboratory Hands-on experience with advanced analytical instrumentation (HPLC, KF, UV/Vis, AA, etc.) Strong understanding of cGMP and data integrity principles Effective communication skills and ability to collaborate across teams Experience training others or supporting competency programs is a plus Other Information: Must be able to climb stairs and ladders when required Must be able to stand for prolonged periods of time Must be able to lift 25 lbs Must be able to perform and review work in a manufacturing work environment. Must be able to work around chemicals, dust, bacteria, biohazards and dust Must be able to support 24-hour manufacturing process

Requirements

B.S. degree in Chemistry, Biochemistry, or related field

Nice To Haves

5 years of demonstrated experience in a GMP laboratory
Hands-on experience with advanced analytical instrumentation (HPLC, KF, UV/Vis, AA, etc.)
Strong understanding of cGMP and data integrity principles
Effective communication skills and ability to collaborate across teams
Experience training others or supporting competency programs is a plus

Responsibilities

Maintaining a safe work environment and working safely
Conduct raw material testing to compendial standards (USP/EP/JP)
Support routine and non-routine testing, troubleshooting, and method diagnostics
Assist with method validation to ensure methods remain reliable and compliant
Manage and Coordination of Chemistry Modular Training Program
Conduct training for Chemistry Lab Personnel and/or coordinates training schedules
Manage method training qualification process to ensure individuals maintain method proficiency and qualification
Assist with CAPAs, efficiency projects, and instrument IQ, OQ, and PQ
Assist with non-routine sample request testing
Effectively communicates with plant personnel, vendors and QC team members
Provide technical understanding of regulations applicable to laboratory testing for cGMP purposes
Assist with scheduling of testing and review
Assist with Chemistry lab scorecard and metrics
Provide support for the site during Quality Audits as needed
Review and approve in process results through LIMS or other controlled systems
Perform other tasks as assigned by QC Manager