QA TECHNICIAN

NICE-PAK PRODUCTS LLC; Maryland Heights (MO); Presencial; USD 52.000 - 76.000; Tempo integral

Resumo da vaga

NICE-PAK PRODUCTS LLC in Maryland Heights seeks a QA/QC technician to monitor quality on packaging lines, sample containers, verify labels, and audit processes under cGMPs to ensure a compliant, high-quality product.

The role requires a high school diploma or GED, 2 years of college coursework preferred, and at least 2 years in a cGMP environment. Proficiency with Word/Excel/Access and an ERP system, plus strong communication and attention to detail, are essential.

Qualificações

• High school diploma or GED required; college coursework preferred.
• Minimum 2 years in a cGMP regulated industry.
• Proficient with Word, Excel, Access and ERP systems.
• Strong communication, organization and attention to detail.

Responsabilidades

• Sample and test incoming containers & closures; release or reject in the system.
• Inspect labels for customer specs and regulatory requirements; maintain samples.
• Perform audits to ensure cGMP compliance and complete paperwork.
• Assist QA management with disposition of quarantined/non-conforming materials.
• Operate electric pallet jack; work across QA areas as needed.

Conhecimentos

Computer literacy

Multitasking

Communication skills

Attention to detail

Formação

High School Diploma or GED

Two years college coursework (preferred)

Ferramentas

Microsoft Word

Microsoft Excel

Microsoft Access

ERP system

Descrição da vaga

Summary:Monitors and measures quality on packaging lines to assure proper monitoring of fill weights, torque specifications, labels and packaging components along with various quality functions to assure that production produces a good quality product.Essential Duties and Responsibilities:Sample and test all incoming containers & closures. Release or reject containers and closures in the computer system.Inspect incoming labels for conformance to customer specifications and regulatory requirements.Maintain retain samples in accordance with cGMPs.Ensure that all samples are pulled and delivered to the QC Lab and Micro Lab.Perform Compounding Tank Inspections for cleanliness.Perform special customer inspections for conformance when required.Assure that all paperwork is accurate and complete prior to turning into the Doc Center.Assist with process audits to ensure adherence to cGMPs, FDA guidance documents and customer specifications. This includes auditing all areas directly or indirectly involved in the manufacturing of drug products; Compounding, Packaging, Receiving, Distribution, QC labs, etc.Conduct product audits to ensure the in-process and packaged product meets customer specifications and cGMPs. This includes inspecting product on the Packaging lines and identifying and reporting non-conforming material.Facilitate with QA Management final disposition of Quarantined and Non-Conforming Materials.Must be able to operate an electric pallet jack on a daily basis.Be flexible and able to work in all QA areas as assignedEducation Requirements:High School Diploma or GED is required. Two years of college level course work is preferred or equivalent knowledge in math, science and computers achieved from work experience and/or on-the-job training.Experience Requirements:Minimum of 2 years’ experience in a cGMP regulated industry is preferred. Ability to work in Microsoft programs (Word, Access, and Excel) and an ERP system is required.Competencies:Works well with computers (ability to input or create spreadsheets, databases, etc.)Demonstrated ability to handle multiple tasks.Requires excellent oral & written communication skills.Ability to communicate cGMP standards to multiple departments.Ability to train associates on cGMPs. Excellent organizational skills and attention to detail.Certificates, Licenses, Registrations:N/ATravel:N/AWork Environment:Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Occasionally lift boxes of products 5-40 lb. frequently lift samples 1-5 lb. Clarity of vision at 20 inches or less, with the critical ability to distinguish colors and adjust eye to bring objects into sharper focus