QC Tech II
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Miami, OK 74354
The primary role of this individual will be to provide quality assurance, quality control, general and administrative QA support services.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
+ Prepares, documents, manages, and provides Material Certificates for completed customer orders.
+ Provide replacement certificates when requested by customer.
+ In accordance with Quality Management System (QMS) prepares, issues, inspects, reviews, and files all Quality Assurance documentation (batch records, inspection records, audits, etc.) associated with production, receiving, shipping and testing operations.
+ Ensures accuracy and auditability for each batch record; assigns lot numbers to batch runs and reports discrepancies to appropriate functional leads.
+ Converts hard copy documentation to electronic media within their area of responsibilities.
+ Uses commercial off the shelf and enterprise software systems to record and document quality and production activities.
+ Keeps copies of all forms required for use by QA department. Responsible for label control and validation of customers’ label requirements.
+ Maintains the label master files, label inventory, and label printers.
+ Prepares and executes Quality Audits and inspections of finished goods, incoming raw materials at staging, packaging, and out-going materials at shipping in accordance with local procedures.
+ Maintains the records of these inspections and audits and ensures their accuracy and completeness.
+ Collects and delivers materials to internal or external laboratory’s to support lot acceptance testing requirements.
+ Schedules, documents, and ships samples for outsource processing and testing.
+ Prepares laboratory data packages for outside analytical services.
+ Serves as a primary contact for Customer inquiries when it relates to outsourced services or certificates.
+ Creates product hold tags, supports process deviations (planned and unplanned) and ship under quarantine processes, and approves materials to ship.
+ Performs visual inspection of finished goods, first piece inspection and product release, in accordance with written procedures.
+ Reviews and approves DuPont shipments.
+ Identifies and recommends potential improvement to existing production and support processes. Supports calibration, pest control, clean room and fume hood certifications, as assigned.
+ Assists and performs duties assigned by Standard Operating Procedures (SOP) and environmental monitoring plans.
+ In collaboration with Leads and Department Managers encourages and maintains open communication with production personnel regarding product quality.
+ Provides Quality department support during their assigned shift to support scheduled production operations.
+ Oversees and/or performs special Quality Department projects and other duties required to meet production deadlines.
+ Other duties as required.
SUPERVISORY RESPONSIBILITIES: None at this time.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE: High school or GED required, Associate’s degree from a two year college, or vocational technical institution preferred. Must have the ability to operate office equipment such as computers, copiers, scanners, label machines, etc. Possess intermediate skills with regards to use of office software applications such as Microsoft Office, LSDocs, Track Wise, Labeling Software and other applications that support Quality Operations.
LANGUAGE SKILLS: Ability to read, write, comprehend and interpret Standard Operating Procedures, Customer Order Requirement Documents (CORDs), work instructions and lab results. Ability to effectively present and explain information, respond to questions from co-workers, managers, clients and customers.
MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in key units of measure, using whole numbers, common fractions, and decimals. Ability to compute rates, ratios, and percentages, and to draw and interpret bar graphs.
ABILITIES: Self-starter with the ability to prioritize and effectively manage work. Ability to multi-task multiple assignments in a fast paced every changing environment. Ability to identify patterns and define problems, collects, and organizes data, establish basic facts and draw reasonable conclusions. Ability to understand oral and/or written instructions and to deal with occasional abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS: None at this time.
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. Examples of but not limited to: employee will routinely be required to walk/stand for periods of time, inspect materials, lift up to 50lbs, operate a computer for periods of time, create and archive records, and archive material samples. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.