QC Supervisor - 2nd Shift

Job Description

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.

Essential Job Responsibilities:

• Supervise QC personnel to support in-process 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 in-process, release and stability 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

Shift: 2:30PM - 11PM, Monday through Friday

Qualifications

• May require Associate Degree or higher education/specialized training/certification, or equivalent combination of education and experience

• 1+-years experience formally or informally leading people, projects and/or programs for entry to this level

• 2+ years’ experience working in a cGMP regulated environment

• HPLC experience

• Knowledge and experience working with USP guidelines, international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support production of APIs, stability and drug product release

• 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 including adherence to Good Documentation Practices and the ability to effectively coach and mentor QC staff reporting to them

• Ability to multi-task and lead various projects and competing priorities: must be able to use discretion in