Title:  Quality Technician

Job Summary

Essential Duties and Responsibilities

• Point of QA contact in the Phoenix / Rockford location.  This position is assigned to the Phoenix location with occasionals shifts at the Rockford location. 
• Organize the QA lab work loads and drive performance across the 4 QA lab shifts.
• Perform and oversee component or product inspection, sampling, analyses following standard methods and procedures, and approval/release.
• Write, review, and revise procedures, work instructions, and any related forms for specific job-related activities.
• Conducts review of batch documentation for GMP Compliance. Works with production personnel to resolve GMP discrepancies. Establishes files for batch documentation.
• Works with databases to collect information and data pertaining to batch documentation.
• Performs QA release of finished product for acceptable materials.
• Disposition NC material in the Bond Room and dispositions NC material per procedures and MRB reviews.
• Assists with the calibration process by recording calibration frequencies, due dates, suppliers, and other calibration duties as required. Maintains organization of calibration activities.
• Store, record and maintain electronic and hard copies of controlled documents and records.
• Performs QA document control functions and upload records in Master Control.
• Coordinates the revision, review, and approval of SOPs and other GMP documents.
• Train existing QA Techs to the material review process for business continuity, provide continued training, as required.
• Support Continuous Improvement program throughout West Phoenix.
• Supports internal / external audits and document control.
• Performs other duties as assigned by the Quality Supervisor or Manager.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules
• Exhibits regular, reliable, punctual and predictable attendance
• Other duties as assigned

Additional Responsibilities

• 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

Education

• Bachelor's Degree Technical Studies or Science or equivalent experience preferred

Work Experience

• 3 years of experience required and
• Minimum 2 years of cGMP experience preferred

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

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

What We Offer

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