Title:  Quality Technician Molding

Job Summary

Essential Duties and Responsibilities

• Assist and directs the activities and resources of Quality Tech group including; work assignments, break scheduling and relief
• Coordinates with other departments to ensure variety of QA support
• Assist with coordination of training and coaching to QA Techs to ensure quality standards and maintained.
• Inspects and release incoming materials. May perform analytical testing, evaluates, records and reports on the chemical and physical properties of various substances and materials to determine product release approval status.
• Review and approve Batch Production Records from each job.
• Compose Non-Conformance Report (NCR) Deviations, Document Change Notices (DCN), Out of Specification(OOS), Work Instructions, Incoming Quality Control (IQC) forms and Engineering Change Requests (ECR’s).
• May create protocols for validation of analytical procedures, perform the validation, calibrate gauges and write reports.
• May compose protocols for Installation Qualification/Operational Qualification (IQ/OQ) of various equipment, perform IQ/OQ.
• Assist in the design & drawing reviews and make recommendations for improvements, clarification, and correctness as needed.
• Assists shift personnel with quality issues and/or measurement techniques.
• Input incoming lots into expiration/retest database.
• Maintain expiration/retest date database for incoming materials. Review retest dates and arrange for testing of materials for retest. Review expiration dates and arrange for disposal of expiring materials.
• Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Maintain working knowledge of computer software packages including MS Office suite, Adobe, MasterControl, LIMS, and LMS
• Collaborate as needed on proposed path forward regarding documentation questions
• Other duties as assigned

Additional Responsibilities

• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain a clean, orderly, and safe workstation and environment at all times.
• Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibit regular, reliable, and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures
• Support new GMP compliance guidance and Data Integrity initiatives

Education

• High School or Equivalent

Work Experience

• Experience: 3-5 years

Preferred Knowledge, Skills and Abilities

• Able to be aware of all relevant standard operating procedures as per Company policy
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Willingness to learn new and review new analytical techniques
• Meet individual and departmental goals as required
• Able to always comply with the company’s quality policy.
• Proficiency with PC and Microsoft Office; Knowledge of QMS Master Control, MeasureLink and other Quality systems is preferred.
• Must be able to prioritize and perform position responsibilities accurately and meet required deadlines.
• Strong attention to detail; Strong problem identification/analysis and solving skills with hands-on approach.
• Excellent verbal and written communication skills; Maintain an organized and clean quality Lab.
• Ability to multi-task and prioritize in a fast-paced environment; Ability to interface with all personnel levels.
• Motivated self-starter with ability to work independently on multiple assignments in a team environment.

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Read and interpret data, information and documents
• Work under deadlines with constant interruptions