Quality Control Technician - Day Shift

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.