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 completing work assignments and establish priorities for the shift, setting standards and working collectively to meet project deadlines and objectives

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least October 24, 2024 or until the job is no longer posted.

The full-time equivalent pay range for this position is $97,920.00 - $153,000.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required: No

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory