QC Supervisor

Agilent Technologies•Frederick, CO

About The Position

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. The QC Supervisor will oversee activities assigned to Quality Control (QC) and supervise a group of QC analysts. They will ensure workload and priorities are met and will be required to supervise staff and perform Laboratory testing and review in support of the workload. The supervisor will also ensure QC operations are in compliance with current Good Manufacturing Practices (cGMP) and other regulatory guidance.

Requirements

Secondary Education with relevant experience
Two years of QC experience
Ability to write and review protocols, reports, and procedures
Knowledge and skill using basic computer software and hardware applications, including Microsoft Word and Excel
Excellent written and oral communication skills
Ability to multi-task and lead various projects and competing priorities

Nice To Haves

Bachelor of Science preferred
Experience working in a cGMP regulated environment
Experience with the handling of Raw Materials
Two years experience formally or informally leading people, projects and/or programs for entry to this level

Responsibilities

Supervise QC personnel to support raw material testing
Exercises judgment within defined procedures and policies to determine appropriate action
Acts as the shift supervisor and becomes actively involved as an analyst as required to meet schedules and resolve problems
Prioritizes and arranges the workload to ensure raw material and in-process testing timelines are met
Delegates effectively and exercises judgment when escalating issues to QC upper Management
Writes, reviews and revises standard operating procedures. associated Quality Control functions, and analytical test methods
Generates, processes and/or reviews analytical data
Reviews data for compliance to specifications and reports anomalous results to the Quality Manager and Quality Assurance, as appropriate
Assists with QC related deviations, inquiries/investigations, and corrective/preventative actions (CAPAs)
Will be directly involved in client Audits and regulatory inspections
Ensures that quality products are designed and manufactured by Agilent, and are in alignment and compliance with national, regional and global regulations, company policies and business objectives
Develops and implements programs and processes to ensure that Agilent products are safe, legal, and meet or exceed customer expectations for regulatory compliance
Oversees and advises quality and/or regulatory activities and drives key strategic programs within assigned area of responsibility
Acts as a change agent to help establish a customer-centered culture
Ensures quality management system procedures were accurate and current
Provides expertise in translating regulatory requirements into practical, workable plans
Represents the company in industry associations and standards bodies and may work with regulatory agencies
May lead development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products
May lead generation and review of documentation used in good manufacturing practices
May supervise audits of production and quality control areas and raw material vendors
Selects, develops and evaluates personnel to ensure the efficient operation of the function
Supervises individual contributors responsible for routine tasks
Assign and direct implementation of tasks and processes
Establishes, maintains business controls and process