RESPONSIBILITIES: • Performing all Quality Control inspection types as assigned by the Quality Control Supervisor (e.g., in-process & final QC inspections, WIP, pkg. and Raw material inspections, etc.) • Conducts first article and line clearance inspections of packaging lines • Conducts pre-weigh line clearance inspections prior to compounding/batching • Conducts compounding and filling equipment sanitization inspections • Maintains Retained FG, Bulk & Raw Material sample storage and logbooks • Coordinates and arranges for finished product microbiological and other testing conducted by external laboratories • Collect, store, test, and distribute samples and ensure prompt customer shipping. • Performs scale verification checks during the first article release • Initiate and lead Non-Conformances and support investigative work • Performs laboratory testing on bulk and finished products (as required)
• Manages storage and cataloging of hardcopy batch and packaging records • Conducts and documents environment bioburden, particle testing, and cleaning validations of compounding and packaging equipment. • Provides backup for incoming component packaging and raw material testing • Conduct training as needed • Must support all Safety initiatives at the site • Assist with administrative tasks such as filing and organizing documentation pertinent to Quality Control inspection • Shares ownership and performs the following as needed: o Line Clearance / First Article / In-Process Inspections o AQL Inspections – Level determined by Customer requirements o Finished Goods releases o Handling of Non-conforming material • May assist with CAPA, deviations, and non-conformance programs by collecting customer information, coordinating investigations across different departments, facilitating investigations, and entering information into the system. (as needed) • Performs other work-related duties as assigned by the Quality Control Supervisor
QUALIFICATIONS: Required • Previous GMP and GDP experience and training • Flexibility to work overtime and weekends as scheduled • Problem Solving and decision-making. • Must be able to speak, write, and read English. Bilingual skills are a plus. • Minimum 3 years related experience in a manufacturing environment, preferably in a quality role. • Able to use standard inspection equipment (calipers, thickness gage, and other gages, etc.). • High school diploma or equivalent; technical degree is a plus.
Competencies • Detail-oriented with good organizational skills. • Good communication and interaction skills. • Able to follow written work instructions. • Ability to work under minimal supervision. • Demonstrated ability to read, understand, and apply the information in technical documentation, procedures, and drawings and understand basic geometric tolerances. • Basic computer skills using Word and Excel.