Setup platform whereby each employee is familiar with the individual daily expectations of workload that needs to be completed.
Monitor daily to deal with external issues that interfere with schedules.
Staff selection incorporating the correct balance with qualification and experience, training, personal development, performance evaluation; help resolve any personal issues relating to work.
Review of daily instrument calibration and verifications, review of logbooks or designate chemist to do so.
Review testing with R&D, schedule workload for samples from mfg and pdn.
Problem solve with colleagues regarding OOS results, discuss additional testing, operation of equipment, meeting to share ideas.
CAPA responsibility.
Review NCRs prior to submission to Lab Manager, check calculations, possible cause with review of batch records.
Review workload priority and staffing requirements with Manager to assure organization priorities are met and communicate priority releases.
Assist with quality and environmental health and safety audits.
Quality Control Analytical Lab experience with HPLC, GC, ICP-OES, UV-VIS, Karl Fischer, etc.
Schedule maintenance services for many different types of Lab equipment.
Interact with customers, other employees and external contractors.
Compliance to Data Integrity requirements.
Assist with investigation of quality issues such Out of Specification, Out of Trends, etc.
Train New Employees.
Manage chemical hygiene program for the laboratory.
Develop and Manage testing methods, protocols and reports.
Manage chemical and consumable stocks
Maintain USP/NF Compendia, ASTM, ISO Stds.
Familiarity with US FDA 21CFR Part 210 & 211 (Drug Product) and Cosmetic GMPs is MANDATORY.
Requirements
Bachelor’s degree in Chemistry or related field
Strong knowledge in GMP, GLP, Root Cause Analysis & Corrective Action Planning Tools
Laboratory management experience preferred, with experience in Cosmetic or Pharmaceuticals desired
5+ years Quality Control Analytical Lab experience with HPLC, GC, ICP-OES, UV-VIS, Karl Fischer, etc
Good interpersonal and written communication
Flexible, ability to multitask and designate
Good organizational skills
Ability to teach/ train employees
Benefits
Medical, Dental, and Vision Insurance
Life Insurance paid 100% by the company
401K after 6 months