Who we are:Charter Medical, LLC is a life sciences company that is committed to designing, developing, and manufacturing quality products to support cell and gene therapy, bioprocessing, and blood management. About the role:The Quality Control Technician conducts inspection and testing activities at various manufacturing stages including incoming, in-process, and final release.3rd shift 11:00 pm-7:00 amWhat you will do:
- Performs in-process and final inspections; including visual, dimensional and functional verifications, as well as inspections for defects, non-conformance and contamination with adherence to Work Instructions (WI's), Visual Inspection Criteria, Standard Operating Procedure (SOP) and internal specifications defined for each product.
- Records inspection results and completes appropriate documentation; assists notification of non-conforming product/processes.
- Follows documented procedures to maintain control of non-conforming products by identifying and segregating products that do not meet specifications and completing appropriate documentation.
- Performs Quality Control (QC) verification of line openings, closing and subsequent line clearances. Records sample collection in current Enterprise Resource Planning (ERP) system.
- Performs verification or calibration of measurement equipment.
- Ensures proper labeling of acceptable material.
- Reviews supplier certifications/packing list to ensure compliance with specification.
- Assists in collection of data for certification of finished products.
- Logs, files, and maintains finished goods retention samples.
- Assists with receiving inspection of raw materials using appropriate sampling plan and measuring/test equipment as needed.
- Assist in all areas within the quality department as needed.
Other Duties
- Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP's, Work Instructions) to successfully accomplish job requirements.
- Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
- Follows gowning procedures in designated areas.
- Follows established safety requirements and adheres to the Health Safety and Environment Management System.
- Performs other job-related responsibilities as assigned.
Who you are:
- High school graduate or equivalent required.
- Two years Quality experience preferred.
- Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
- Ability to comprehend and follow SOP's, WI's, policies, and procedures such a safety, quality, and HR that are written in English.
- Possess basic mathematical skills to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Basic understanding of GMP and working within FDA regulated industries preferred.
- Basic computer skills including ability to use MS Outlook and automated manufacturing and quality systems.
- Excellent interpersonal skills with ability to get along well with others and work in a team environment.
- Ability to properly complete paperwork as required according to work instructions, standards, or other specifications.
- Excellent dependability and reliability.
- Willingness to accept change, learn, and work with new processes.
- Familiarity with an ERP system and Quality Management System (eQMS) preferred.
- Must be able to work extended hours when required.
- 20/20 vision (with corrective eyeglasses) and ability to pass a color perception test.
Perks / Benefits:
- Generous Paid Time Off
- Paid Breaks
- Quarterly Bonuses
- 401k with excellent company match
- Health Insurance with multiple plans to choose form
- Paid Short Term and Long Term Disability